Testolic 100 mg is how many ml

Patient Info Service - information for patients

1. What Tramal 100 mg / ml oral solution is and what it is used for

Tramadol - the active ingredient in this medicine - is a centrally acting pain reliever from the group of opioids. Its pain-relieving effect is achieved through its action on specific nerve cells in the spinal cord and the brain.

This medicine is used to treat moderate to severe pain.

2. What you need to know before you take Tramal 100 mg / ml oral solution?

Do not take Tramal 100 mg / ml oral solution

  • if you are allergic to tramadol, menthol, cineol or any of the other ingredients of this medicine (listed in section 6).

  • acute poisoning from alcohol, sleeping pills, painkillers or other psychotropic drugs (drugs that affect mood and emotional life).

  • if you are also taking MAO inhibitors (certain medicines that counteract depression) or have taken them within the last 14 days before treatment with this medicine (see “Taking Tramal 100 mg / ml oral solution with other drugs ").

  • if you have epilepsy and treatment cannot adequately control it.

  • as a substitute for drug withdrawal.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Tramal 100 mg / ml oral solution,

  • if you think you are dependent on other pain relievers (opioids).

  • if you have impaired consciousness (if you feel close to fainting).

  • if you are in shock (a cold sweat may be a sign of this).

  • if you suffer from conditions with increased intracranial pressure (possibly after head injuries or brain diseases).

  • if you have difficulty breathing.

  • if you are prone to epilepsy or seizures.

  • if you have liver or kidney problems.

Sleep-related breathing disorders

Tramal 100 mg / ml oral solution contains an active substance that belongs to the group of opioids. Opioids can cause sleep-related breathing disorders such as central sleep apnea (shallow breathing or cessation of breathing during sleep) and sleep-related hypoxemia (low levels of oxygen in the blood).

The risk of developing central sleep apnea depends on the opioid dose. If you develop central sleep apnea, your doctor may consider reducing your total opioid dose.

Epileptic fits have been reported in patients taking tramadol at the recommended dose. The risk may increase if the recommended maximum daily dose of 400 mg tramadol is exceeded.

Please note that this medicine can lead to emotional and physical dependence. With prolonged use, the effect of this drug may decrease, so that higher amounts of drug have to be taken (tolerance development). In patients who tend to abuse or become dependent on drugs, treatment with this drug should therefore only be carried out for a short period and under strict medical supervision.

Tramadol is converted by an enzyme in the liver. Some people have a modification of this enzyme, which can have different effects. Some people may not get adequate pain relief from this, and others may be more likely to experience serious side effects. If you notice any of the following side effects, stop taking this medicine and seek medical attention immediately: slow or shallow breathing, confusion, sleepiness, small pupils, nausea, vomiting, constipation, loss of appetite.

Please also tell your doctor if you experience any of these problems while taking Tramal 100 mg / ml oral solution or if these information applied to you in the past.

Other medicines and Tramal 100 mg / ml oral solution

Tell your doctor or pharmacist if you are taking / using, have recently taken / used or may take / use any other medicines.

Tramal 100 mg / ml oral solution must not be taken together with MAO inhibitors (certain medicines used to treat depression) (see “Tramal 100 mg / ml oral solution must not be taken”).

The pain relieving effects of Tramal 100 mg / ml oral solution may be reduced and the duration of its effects may be shortened if you take medicines containing any of the following active substances:

  • Carbamazepine (for epileptic seizures)

  • Ondansetron (for nausea)

Your doctor will tell you whether you can take this medicine and, if so, what dose.

The risk of side effects increases

  • if you are taking Tramal 100 mg / ml oral solution and medicines that also have a depressant effect on the brain at the same time. You may feel drowsy or faint. If this happens, please inform your doctor. These other medicines include certain pain relievers, such as morphine and codeine (also used as cough suppressants), and alcohol.

    The simultaneous use of Tramal 100 mg / ml oral solution and sedatives or sleeping pills (e.g. benzodiazepines) increases the risk of drowsiness, difficulty breathing (respiratory depression) and coma and can be life-threatening. For this reason, concomitant use should only be considered if no other treatment options are available.

    However, if your doctor prescribes Tramal 100 mg / ml oral solution with sedative medicinal products, the dose and duration of concomitant treatment should be limited by your doctor.

    Please inform your doctor about all sedating medicines you are taking and strictly follow your doctor’s dose recommendations. You may find it helpful to tell friends or family members to look out for any of the above signs and symptoms. Contact your doctor if you experience these symptoms.

  • if you are taking medicines that can cause convulsions (fits), such as certain medicines for depression or psychosis. The risk of seizures may increase if you are taking this medicine at the same time. Your doctor will tell you whether Tramal 100 mg / ml oral solution is right for you.

  • if you are taking certain medicines for depression. The effects of these medicines and Tramal 100 mg / ml oral solution can interact and you may experience symptoms such as involuntary, rhythmic muscle twitching, including eye twitching (twitching of the muscles that control eye movement), restlessness, excessive sweating, involuntary Tremors, increased reflexes, increased muscle tension, body temperature over 38 ° C.

  • if you are taking coumarin anticoagulants (medicines that prevent normal blood clotting) such as warfarin at the same time as this medicine. The anticoagulant effects of these medicines can be influenced and bleeding can occur

Tramal 100 mg / ml oral solution with food and alcohol

Do not drink alcohol while taking this medicine, as its effects may be increased. Food does not affect the way Tramal 100 mg / ml oral solution works.

Children and adolescents

Use in children with breathing problems

Tramadol is not recommended in children with breathing problems, as symptoms of tramadol toxicity may worsen in these children.

Pregnancy and fertility

Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breast-feeding, if you suspect you may be pregnant or planning to become pregnant.

Little information is available on the safety of tramadol during pregnancy. Therefore, you should not take Tramal 100 mg / ml oral solution if you are pregnant.

Repeated use of this medicine during pregnancy may cause the unborn child to get used to tramadol and, as a result, cause withdrawal symptoms in the newborn after birth.

Experience from its use in humans suggests that tramadol does not affect male or female fertility.

Breastfeeding

Tramadol passes into breast milk. For this reason, you should not take Tramal 100 mg / ml oral solution more than once if you are breast-feeding; Conversely, if you take Tramal 100 mg / ml oral solution more than once, you should interrupt breastfeeding.

Driving and using machines

Tramal 100 mg / ml oral solution can cause dizziness, light-headedness and visual disturbances (blurred vision) and thus affect your ability to react. If you have the feeling that your ability to react is impaired, do not drive a car or any other vehicle, do not use electrical tools or machines, and do not work without a secure grip!

Tramal 100 mg / ml oral solution contain sucrose macrogol glycerol hydroxystearate, propylene glycol and sodium

This medicine contains sucrose. Please take Tramal 100 mg / ml oral solution only after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

Tramal 100 mg / ml oral solution can be harmful to teeth (tooth decay).

Macrogol glycerol hydroxystearate can cause stomach upset and diarrhea.

This medicine contains 150 mg propylene glycol per ml.

This medicinal product contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially 'sodium-free'.

3. How to take Tramal 100 mg / ml oral solution?

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The dosage should be adjusted according to the severity of your pain and your individual sensitivity. In principle, the lowest dose that has an analgesic effect should be selected. Do not take more than 160 drops of Tramal 100 mg / ml oral solution (e.g. 8 times 20 drops, equivalent to 400 mg of tramadol hydrochloride) daily, unless your doctor has expressly prescribed this.

Unless otherwise prescribed by your doctor, the usual dose is:

Adults and adolescents from 12 years

If the pain is moderately severe, 20 drops of Tramal 100 mg / ml oral solution (equivalent to 50 mg tramadol hydrochloride) are taken as a single dose. If there is no relief from pain within 30 to 60 minutes, a second single dose can be taken.

If a higher requirement is to be expected in the case of severe pain, 40 drops of Tramal 100 mg / ml oral solution (equivalent to 100 mg tramadol hydrochloride) are taken as a single dose.

The effect lasts for 4 to 6 hours, depending on the pain.

children

This medicine is not intended for use in children under 1 year of age.

Children from 1 to 11 years of age preferably take this drug with the dropper device, since a more precise dose based on body weight can be achieved here. Children aged 1 to 11 years receive 4 to 8 drops per 10 kilograms of body weight as a single dose (corresponding to 1 to 2 mg tramadol hydrochloride per kilogram of body weight). A daily dose of 32 drops per 10 kg of body weight (equivalent to 8 mg of tramadol hydrochloride per kilogram of body weight) or 160 drops (equivalent to 400 mg of tramadol hydrochloride, the smaller of the two doses to be administered, unless your doctor tells you to) should not be exceeded this is expressly prescribed.

You will find more detailed information on the body weight-related dosage in children at the end of this leaflet.

Elderly patients

The elimination of tramadol may be delayed in elderly patients (over 75 years of age). If this applies to you, your doctor may recommend that you extend the intervals between doses.

Severe liver or kidney failure (insufficiency) / dialysis patients

If you have impaired liver and / or kidney function, your doctor may recommend that you extend the intervals between doses.

How and when should you take this medicine?

To take.

Take Tramal 100 mg / ml oral solution, also with or without food, with a little liquid or sugar. Further information on the application can be found at the end of this leaflet.

How long should you take this medicine?

Do not take Tramal 100 mg / ml oral solution for longer than absolutely necessary. If long-term pain treatment appears necessary, your doctor will check regularly (if necessary by taking breaks from using it) whether you should continue to take this medicine and, if so, what dose.

Please talk to your doctor or pharmacist if you have the impression that the effect of Tramal 100 mg / ml oral solution is too strong or too weak.

If you take more Tramal 100 mg / ml oral solution than you should

If you accidentally take an extra dose of this medicine it will usually not have any adverse effects. Take the next dose of Tramal 100 mg / ml oral solution as prescribed.

If the drug is taken in excessively high amounts, pupils may be constricted, vomiting, a drop in blood pressure, an accelerated heartbeat, circulatory collapse, impaired consciousness up to a coma (deep unconsciousness), epileptiform seizures and reduced breathing and even stopping breathing. Call a doctor for help immediately if these signs occur!

If you forget to take Tramal 100 mg / ml oral solution

If you forget to take this medicine, your pain may come back. Do not take a double dose to make up for the forgotten dose, just carry on as before.

If you stop taking Tramal 100 mg / ml oral solution

If you interrupt or stop treatment with this medicine prematurely, it is likely that the pain will come back. If you want to stop the treatment because of unpleasant side effects, please contact your doctor.

In general, stopping treatment with Tramal 100 mg / ml oral solution will have no after-effects. However, after-effects may occur in a small number of people who have been taking this medicine for a long time and who suddenly stop taking the medicine. You may feel restless, anxious, nervous, or shaky. You could be hyperactive, have trouble sleeping, or have gastrointestinal discomfort. Very few people may have panic attacks, hallucinations, abnormal sensations such as tingling, prickling and numbness, or ringing in the ears (tinnitus). Other unusual symptoms of the central nervous system, such as confusion, delusion, changes in the perception of oneself (depersonalization) and of reality (derealization), and paranoia, have been observed very rarely. If you get any of these side effects after stopping treatment with this medicine, please contact your doctor.

If you stop taking tramadol:

You should only stop suddenly if your doctor tells you to. If you want to stop taking your medicine, discuss this with your doctor first; this is especially true if you have been taking it for a long time. Your doctor will advise you when and how to stop taking the medicine; this may be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

If you have any further questions on the use of the medicinal product, ask your doctor or pharmacist.

4. What side effects are possible?

Like all medicines, this medicine can have side effects, although not everybody gets them.

You should see a doctor immediately if you experience symptoms of an allergic reaction such as swelling of the face, tongue and / or throat and / or difficulty swallowing or hives with difficulty breathing.

The most common side effects that occur during treatment with Tramal 100 mg / ml oral solution are nausea and dizziness, which occur more often than 1 in 10 people.

Very common (affects more than 1 in 10 people):

Dizziness, nausea.

Common (affects 1 to 10 users in 100):

Headache, drowsiness, exhaustion, vomiting, constipation (constipation), dry mouth, sweating (hyperhidrosis).

Uncommon (affects 1 to 10 users in 1,000):

Influence on the heart and circulatory regulation (palpitations, accelerated heartbeat [tachycardia], attacks of weakness [orthostatic hypotension] or circulatory collapse [circulatory collapse]). These side effects can occur in particular with upright posture and physical exertion.

Nausea, stomach discomfort (e.g. stomach pressure, feeling of fullness), diarrhea (diarrhea).

Skin reactions (e.g. itching, rash).

Rare (affects 1 to 10 users in 10,000):

Allergic reactions (e.g. shortness of breath [dyspnea], wheezing noises [wheezing], accumulation of water in the tissue [angioneurotic edema]) and shock reactions (sudden circulatory failure) have occurred in very rare cases.

Slow heartbeat (bradycardia).

Increase in blood pressure.

Wrong sensations on the skin (such as tingling, prickling, numbness), tremors (tremor), epileptiform seizures, involuntary muscle twitching, coordination disorders, temporary unconsciousness (syncope), speech disorders.

Epileptiform seizures occurred predominantly after the use of high doses of tramadol or after the simultaneous use of medicinal products that can trigger seizures.

Changes in appetite.

Hallucinations, confusional states, insomnia, delirium, anxiety and nightmares.

Psychological complaints can occur after treatment with this medicinal product, although their intensity and nature can vary from person to person (depending on the personality of the patient and the duration of use). This can involve changes in mood (usually elevated, occasionally also irritated mood), changes in activity (usually dampening, occasionally increasing) and a reduction in sensory perception and recognition, which can lead to errors in decision-making behavior (reduction in sensory and cognitive performance), act.

Drug addiction can occur.

Withdrawal reactions may occur after stopping the drug (see "If you stop taking Tramal 100 mg / ml oral solution").

Blurred vision, constriction of the pupils (miosis), extreme dilation of the pupils (mydriasis).

Slowed breathing (respiratory depression), difficulty breathing (dyspnoea).

A worsening of asthma has been reported, but a causal connection with the active ingredient tramadol could not be established.

If the recommended doses are exceeded or other drugs that have a depressant effect on brain function are used at the same time, breathing may become slower.

Decreased muscle strength (motor weakness).

Difficult or painful urination, less urine than normal (micturition disorders and dysuria).

Very rare (less than 1 user in 10,000):

Increases in liver enzymes.

Not known (frequency cannot be estimated from the available data):

Drop in blood sugar levels.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly via the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: http://www.bfarm.de Show. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Tramal 100 mg / ml oral solution

Store drug out of reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the bottle label after "EXP". The expiry date refers to the last day of the month.

After first opening, the solution must not be used for more than 12 months.

This medicinal product does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need. This measure helps to protect the environment.

6. Contents of the pack and other information

What Tramal 100 mg / ml oral solution contains

The active substance is: tramadol hydrochloride.

1 ml Tramal 100 mg / ml oral solution contains 100 mg tramadol hydrochloride.

40 drops correspond to 1 ml solution, so 1 drop contains 2.5 mg tramadol hydrochloride.

The other ingredients are:

Glycerol 85%,

Potassium sorbate,

Macrogol glycerol hydroxystearate,

Propylene glycol,

Sodium cyclamate,

Saccharin Sodium 2 H2O,

Sucrose,

purified water,

Flavorings (mint oil [partially menthol-free], aniseed flavor).

What Tramal 100 mg / ml oral solution looks like and contents of the pack

Clear, slightly viscous, colorless to slightly yellowish solution.

This medicine is available in packs of 10 ml (with a dropper), 20 ml (with a dropper), 50 ml (with a dosing pump) and 100 ml (with a dosing pump) oral solution.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Grünenthal GmbH • 52099 Aachen

Tel .: 0241 569-1111

Fax: 0241 569-1112

E-mail: [email protected]

This leaflet was last revised in September 2019.

Note on tamper-evident security

For your safety, the Tramal dropper bottles are supplied by the manufacturer in tamper-evident packaging.

The outer boxes of this pack are glued. You can only guarantee the original content if the perforation and packaging are undamaged.

The dropper bottle is provided with a tamper-evident ring. You can only guarantee the original content if the dropper cap is undamaged.

If the packaging is damaged, please speak to your pharmacist.

Note on the fill level

Due to the differences in the wall and bottom thicknesses of different glass bottles due to the manufacturing process, the liquid level of originally closed bottles of this drug can fluctuate by a few millimeters.

Application note

The Tramal dropper bottle has a child-resistant screw cap.

To open the closure must be screwed down under strong pressure. Close the cap tightly after use.

For removal Hold the bottle straight down and tap the bottom of the bottle gently with your finger until the first drops come out.

Number of drops

Tramadol hydrochloride content

1 drop

2.5 mg

5 drops

12.5 mg

10 drops

25 mg

15 drops

37.5 mg

20 drops

50 mg

25 drops

62.5 mg

30 drops

75 mg

35 drops

87.5 mg

40 drops

100 mg

Note on the dosage of Tramal 100 mg / ml oral solution in children over one year of age

The following table shows typical examples for the respective age groups (1 drop of Tramal 100 mg / ml oral solution contains approx. 2.5 mg tramadol hydrochloride, see also "How should Tramal 100 mg / ml oral solution be taken?"):

Age

body weight

Number of drops

1 year

10 kg

4 to 8

3 years

15 kg

6 to 12

6 years

20 kg

8 to 16

9 years

30 kg

12 to 24

11 years

45 kg

18 to 36