Gemadol 50 mg, 100 mg, 150 mg, and 200 mg prolonged-release capsules, hard
tramadol hydrochloride
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, but you will not feel it as much.
1. What Gemadol Prolonged-Release Capsules, And What Are Gemadol Used For
Gemadol prolonged-release capsules treat moderate to severe pain (for example, after surgery or an injury).
Tramadol hydrochloride in Gemadol prolonged-release capsules may also be approved for treating other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have 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 time.
- You are addicted to morphine.
- You have severe renal or hepatic impairment.
- You have recently had a head injury or 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 anaesthesia.
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
- 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
- Low blood pressure
This may be a sign of adrenal insufficiency (low cortisol levels). 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 simultaneously.
If you tend to drug addiction or abuse, you should only take Gemadol prolonged-release capsules for short periods. Please inform your doctor about this because he/she may 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 into the liver by an enzyme. Some people have a variation of this enzyme which can affect different people differently. 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.
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, pharmacist, or dentist if you 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 increases 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 simultaneously.
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 those that control eye movements
- Anxiety
- Heavy sweating
- Tremors
- Exaggerated reflexes
- Increased muscle tension
- Body temperature above 38 ° C.
Drugs that act on the nervous system, such as
- Sleeping pills
- Sedatives
- 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
be affected if you take Gemadol prolonged-release capsules simultaneously.
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 can be fatal.
Therefore, concomitant use should only be considered when other treatment options are impossible.
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 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 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. 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 Gemadol prolonged-release capsules are affecting you.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects 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 your doctor has told you 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.
- The first dose should be adjusted according to how severe the pain is and your pain sensitivity. Generally, it would be best if you took the lowest dose, which provides pain relief.
- Swallow the capsules whole with water without chewing.
- If you have difficulty swallowing, you can open the capsules. You must open them carefully by pulling and twisting each end over a spoon so that all the grains are 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. It would be best if you normally took 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. Use in the elderly For elderly patients (over 75 years of age). Tramadol may take longer to disappear from the body. If this affects you, your doctor may recommend prolonging the time between doses.
Use in patients with severe hepatic or renal failure/dialysis patients Patients with severe hepatic and renal failure should not take Gemadol prolonged-release capsules. If you have mild or moderate liver and 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
It would help if you did not suddenly stop taking this medicine unless your doctor tells you to. If you want to stop taking your medicine, 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 treated with Gemadol prolonged-release capsules for a long time may feel unwell if they suddenly stop treatment. You may feel anxious, anxious, nervous or shivering. You may become hyperactive, have difficulty sleeping or have gastrointestinal problems. Contact your doctor if you experience any of these side effects after stopping treatment with Gemadol prolonged-release capsules.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible Gemadol Side Effects
Gemadol prolonged-release capsules can cause side effects like all medicines, although not everybody gets them.
The most serious side effects that may occur are
- Allergic reaction
- Shortness of breath
- Wheezing
- Swelling of the face or throat
- Anaphylactic reaction
- A very severe allergic reaction leads to shortness of breath
- Changes in heart rate
- Lethargy
- Collapse or unconsciousness due to a drop in blood pressure
- 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
- Nausea
Common (may affect up to 1 in 10 people)
- Headache
- Drowsiness (fatigue)
- Constipation
- Dry mouth
- Sweating
Uncommon Gemadol side effects (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 under physical stress.
- Pruritus, rash
- Nausea
- Feeling of bloating
Rare (may affect up to 1 in 1,000 people)
- Changes in appetite
- Psychological influences such as changes in mood, activity level and perception
- Hallucinations
- Confusion
- Restlessness
- Sleep disorders
- 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)
- Haemorrhoids
- 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 include
- Worry
- Anxiety
- Nervousness
- Difficulty sleeping
- Restlessness
- Tremors
- Gastrointestinal upset (see section 3. How to take Gemadol prolonged-release capsules).
Reporting of side effects
Talk to your doctor, pharmacist, or nurse if you get any side effects. 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 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 that are 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 indigotin (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 The Contents Of The Pack
- Depot capsule.
- Gemadol 50 mg prolonged-release capsules are dark green and labelled T50SR.
- Gemadol 100 mg prolonged-release capsules are white and marked T100SR.
- Gemadol 150 mg prolonged-release capsules are dark green and labelled 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 time.
- All capsules are packaged in PVC / PVDC – aluminium blisters containing 10 capsules. Each pack contains 1, 2, 3, 5, 6 or 10 blisters, i.e. 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 50 mg |
| 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 |