50 mg, 100 mg, 150 mg, and 200 mg prolonged-release capsule, hard
tramadol hydrochloride

1. What Gemadol prolonged-release capsules are and what they are used for

Gemadol prolonged-release capsules belong to a group of medicines called analgesics, commonly known as painkillers or painkillers. The active substance tramadol hydrochloride prevents the pain signal from being sent to the brain and also acts in the brain, which makes the pain not felt. This does not mean that Gemadol prolonged-release capsules stop the pain itself, but you will not feel it as much.

Gemadol prolonged-release capsules are used to treat moderate to severe pain (for example, after surgery or after an injury).

Tramadol hydrochloride contained in Gemadol prolonged-release capsules may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before taking Gemadol prolonged-release capsules

Do not use Gemadol prolonged-release capsules:

  • if you are allergic to tramadol hydrochloride or any of the other ingredients of this medicine (listed in section 6) and have a skin rash, swelling of the face or difficulty breathing
  • if you are taking, or have taken in the last two weeks, monoamine oxidase inhibitors ( MAOIs ) to treat depression (see section 2, “Other medicines and Gemadol prolonged-release capsules”)
  • if you suffer from epilepsy that is not well controlled with treatment
  • if you have drunk alcohol and feel dizzy or drunk
  • if you have taken more than the prescribed dose of sleeping pills, antipsychotics, antidepressants (antipsychotics and antidepressants are drugs that affect mood / mood) or other painkillers, which can slow down your breathing and ability to react

Warnings and cautions

Talk to your doctor or pharmacist before taking Gemadol prolonged-release capsules if:

  • you have had an allergic reaction to a morphine-like medicine.
  • you have been taking Gemadol prolonged-release capsules or other medicines that contain tramadol for a long period of time.
  • you are addicted to morphine.
  • you have severe renal or hepatic impairment.
  • you have recently had a head injury or have very severe headaches that make you nauseous.
  • you have had seizures or are suffering from epilepsy .
  • you have asthma or difficulty breathing.
  • you will need surgery under anesthesia.

Sleep-related respiratory disorders

Gemadol can cause sleep-related respiratory disorders such as sleep apnea (respiratory arrest during sleep) and sleep-related hypoxemia (low oxygen content in the blood). Symptoms may include shortness of breath during sleep, awakening during the night due to shortness of breath, difficulty maintaining sleep, or severe drowsiness during the day. Contact a doctor if you or anyone else notices these symptoms. Your doctor may consider lowering your dose.

Talk to your doctor if you experience any of the following symptoms while taking Gemadol:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This may be a sign of adrenal insufficiency (low levels of cortisol ). Contact a doctor if you get these symptoms. Your doctor will decide if you need to take hormone replacement therapy.

In rare cases, Gemadol prolonged-release capsules may cause seizures. The risk increases if the recommended daily dose is exceeded or if you are taking antidepressants or antipsychotics at the same time.

If you have a tendency to drug addiction or abuse, you should only take Gemadol prolonged-release capsules for short periods. Inform your doctor about this because he/she may then want to follow your pain treatment more closely.

You should not take Gemadol prolonged-release capsules to treat withdrawal symptoms if you are addicted to drugs.

Tramadol is converted in the liver by an enzyme. Some people have a variation of this enzyme and it can affect different people in different ways. Some people may not get enough pain relief, while others are at greater risk for serious side effects. If you get any of the following side effects, stop taking this medicine and see a doctor immediately: slow or shallow breathing, confusion, drowsiness, small pupils, nausea or vomiting, constipation, poor appetite.

Children and young people

Gemadol prolonged-release capsules should not be used in children under 12 years of age.

Use in children with respiratory problems

Tramadol is not recommended for children with respiratory problems as the symptoms of tramadol poisoning may be worse in these children.

Other medicines and Gemadol prolonged-release capsules

Tell your doctor or pharmacist or dentist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Do not take Gemadol prolonged-release capsules at the same time as, or within 14 days of taking, so-called monoamine oxidase inhibitors (moclobemide or phenelzine for depression, selegiline for Parkinson’s disease ).

The analgesic effect of Gemadol prolonged-release capsules may be reduced and the duration of action may be shortened if you take other medicines containing:
– Carbamazepine (for epilepsy )
– Buprenorphine, nalbufine or pentazocine (painkiller)
– Ondansetron (for nausea)

Your doctor will tell you if you should take Gemadol prolonged-release capsules and in what dose.

The risk of side effects is increased if you take medicines that can cause seizures (seizures), such as certain antidepressants and antipsychotic medicines. The risk of having a seizure may increase if you take Gemadol prolonged-release capsules at the same time.

The risk of side effects increases if you take certain antidepressants. Gemadol prolonged-release capsules can affect these medicines and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control eye movements, anxiety, heavy sweating, tremors, excessive reflexes, increased muscle tension, and body temperature above 38 ° C. 

Drugs that act on the nervous system such as sleeping pills, sedatives, and painkillers can make you feel drowsy and faint if taken with Gemadol prolonged-release capsules.

Anticoagulants (blood thinners), such as warfarin. The effect of these drugs can

is affected if you take Gemadol prolonged-release capsules at the same time.

Tell your doctor if you are taking any of these medicines.

Concomitant use of Gemadol releases capsules and soothing ( sedative ) drugs or drugs for sleep disorders such as benzodiazepines or similar drugs increase the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and can be fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

If your doctor prescribes Gemadol prolonged-release capsules at the same time as sedatives, the dose and treatment time should be limited by your doctor.

Tell your doctor if you are taking any sedative or anti-sleep medication and carefully follow your doctor’s dose recommendations. It may be helpful to inform friends or relatives about paying attention to the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.

Gemadol prolonged-release capsules with food, drink and alcohol

Gemadol prolonged-release capsules should be taken with some water, with or without food. Do not drink alcohol during treatment with this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Gemadol prolonged-release capsules should not be taken during pregnancy or breastfeeding. This is because it is not yet known how safe it is to take this medicine if you are pregnant. Contact your doctor if you become pregnant during your treatment.

Breast-feeding
Tramadol is excreted in human milk. Therefore, you should not take Gemadol prolonged-release capsules more than once during breastfeeding. Or alternatively, if you take Gemadol prolonged-release capsules more than once, you should stop breastfeeding.

Driving and using machines

Gemadol prolonged-release capsules may cause drowsiness and this effect may be exacerbated by alcohol, antihistamines, and other anti-depressant drugs that may cause drowsiness. Do not drive or use machines if you feel that Gemadol prolonged-release capsules are affecting you.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Gemadol prolonged-release capsules contain sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine 

How to take Gemadol prolonged-release capsules

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Dose one should be adjusted according to how severe the pain is and your individual pain sensitivity. Generally, you should take the lowest dose one that provides pain relief.

Swallow the capsules whole with water, without chewing.

If you have difficulty swallowing, you can open the capsules. You have to open them very carefully by pulling and twisting each end over a spoon so that all the grains end up in the spoon. Do not chew. Swallow all grains with water.

Dosage for adults and adolescents from 12 years of age

The usual starting dose is 50-100 mg twice daily, morning and evening. Your doctor may increase this dose up to 150-200 mg twice daily depending on the severity of your pain. You should normally take Gemadol prolonged-release capsules every 12 hours, at the same time each morning and evening.

The maximum dose is usually 400 mg daily.

Use in children 
Under 12 years of age – Gemadol prolonged-release capsules should not be used by children under 12 years of age.  Use in the elderly For elderly patients (over 75 years of age) it may take longer for tramadol to disappear from the body. If this affects you, your doctor may recommend that you prolong the time between doses.

 

Use in patients with severe hepatic or renal failure/dialysis patients Patients with severe hepatic and/or renal failure should not take Gemadol prolonged-release capsules. If you have mild or moderate liver and/or kidney failure, your doctor may recommend prolonging the time between doses.

If you take more Gemadol prolonged-release capsules than you should

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Gemadol prolonged-release capsules

Do not take a double dose to make up for a forgotten dose .

If you stop taking Gemadol prolonged-release capsules

You should not suddenly stop taking this medicine unless your doctor tells you to. If you want to stop taking your medicine, first discuss it with your doctor, especially if you have been taking it for a long time. Your doctor will tell you when and how to stop, which can be done by gradually lowering your dose to reduce the risk of developing unnecessary side effects (withdrawal symptoms).

Patients who have been treated with Gemadol prolonged-release capsules for a long time may feel unwell if they then suddenly stop treatment. You may feel anxious, anxious, nervous or shivering. You may become hyperactive, have difficulty sleeping or have gastrointestinal problems. If you experience any of these side effects after stopping treatment with Gemadol prolonged-release capsules, contact your doctor.


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

4. Possible side effects

Like all medicines, Gemadol prolonged-release capsules can cause side effects , although not everybody gets them.

The most serious side effects that may occur are allergic reaction (shortness of breath, wheezing and swelling of the face or throat), anaphylactic reaction (a very severe allergic reaction leading to shortness of breath, changes in heart rate , lethargy, collapse or unconsciousness due to a drop in blood pressure) or seizures. If you get any of these symptoms, stop taking Gemadol prolonged-release capsules immediately and contact your doctor.

Very common (may affect more than 1 user in 10)

  • Dizziness
  • Vomiting and nausea.

Common (may affect up to 1 in 10 people)

  • Headache
  • Drowsiness, drowsiness (fatigue)
  • Constipation, dry mouth
  • Sweating

Uncommon (may affect up to 1 in 100 people)

  • Fast heart rate , palpitations, sudden drop in blood pressure. These side effects can occur especially with intravenous administration and in patients who are under physical stress.
  • – pruritus , rash
  • – Nausea, feeling of bloating

Rare (may affect up to 1 in 1,000 people) 

  • Changes in appetite
  • Psychological influence such as changes in mood, activity level and perception. Hallucinations, confusion, restlessness, sleep disorders and nightmares.
  • Stinging sensation and tremors
  • Slow pulse , increased blood pressure
  • Muscle weakness
  • Bladder emptying (difficult or painful to throw water)
  • Dimsyn

Very rare (may affect up to 1 in 10,000 users)

  • Hemorrhoids
  • Dizziness
  • Asthma and shortness of breath
  • Elevated liver enzymes

Has been reported (occurs in an unknown number of users)

Reduction of blood sugar levels

– Hiccups

Withdrawal symptoms such as worry, anxiety, nervousness, difficulty sleeping, restlessness, tremors and gastrointestinal upset (see section 3. How to take Gemadol prolonged-release capsules).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Gemadol prolonged-release capsules

  • Do not store above 25 ° C.
  • Store in the original package. Moisture sensitive.
  • Keep out of sight and reach of children.
  • Use Gemadol prolonged-release capsules before the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is tramadol hydrochloride.

Gemadol 50 mg prolonged-release capsule contains 50 mg tramadol hydrochloride

Gemadol 100 mg prolonged-release capsule contains 100 mg tramadol hydrochloride

Gemadol 150 mg prolonged-release capsule contains 150 mg tramadol hydrochloride

Gemadol 200 mg prolonged-release capsule contains 200 mg tramadol hydrochloride

Other ingredients in the contents of the capsule are:

sugar pellets (sucrose and maize starch)

colloidal anhydrous silica

ethylcellulose

shellack

talc.

The capsule shell contains:

gelatine

titanium dioxide (E171)

The 50 and 150 mg capsules also contain yellow iron oxide (E172) and indigotine (E132)

The 200 mg capsules also contain yellow iron oxide (E172)

The ink contains:

shellack

black iron oxide (E172)

propylene glycol

ammonium hydroxide

What the medicine looks like and contents of the pack

Depot capsule .

Gemadol 50 mg prolonged-release capsules are dark green and labeled T50SR.

Gemadol 100 mg prolonged-release capsules are white and marked T100SR.

Gemadol 150 mg prolonged-release capsules are dark green and labeled T150SR.

Gemadol 200 mg prolonged-release capsules are yellow and marked T200SR.

This medicine is in the form of a prolonged-release capsule . The capsules release the active substance for a longer period of time.

All capsules are packaged in PVC / PVDC – aluminum blisters containing 10 capsules. Each pack contains 1, 2, 3, 5, 6 or 10 blisters, ie. each pack contains 10, 20, 30, 50, 60 or 100 capsules per pack. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Meda AB

Box 906

170 09 Solna

Manufacturer

Temmler Pharma GmbH

Temmlerstrasse 2

35039 Marburg

Germany

This medicinal product is authorized under the European Economic Area under the names:

Belgium Tradonal Retard 50/100/150/200 mg, prolonged-release gelsTradonal Retard 50/100/150/200 mg, extended release capsules, hardTradonal Retard 50/100/150/200 mg, hard capsules, retarded
Denmark Gemadol Retard
France Zamudol LP 50/100/150/200 mg, prolonged release gel
Germany Travex retard 50/100/150/200 mg hard capsules, retarded
Italy Tradonal SR 50/100/150/200 mg 30/60 capsule rigid rilascio prolungato
Luxembourg
Tradonal Retard 50/100/150/200 mg, prolonged-release gelsTradonal Retard 50/100/150/200 mg, extended release capsules, hardTradonal Retard 50/100/150/200 mg, hard capsules, retarded
Netherlands Tramadol HCl Retard Mylan 50/100/150/200 mg
Portugal Travex Capsule lasts for prolonged release
Spain Tradonal retard 50/100/150/200 mg prolonged release capsules
Sweden Gemadol 50/100/150/200 mg prolonged-release hard capsule
United Kingdom (NI) Zamadol SR 50/100/150/200 mg prolonged-release hard capsules

Muhammad Nadeem

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