100 mg, 150 mg, and 200 mg prolonged-release tablets are 
tramadol hydrochloride

What Dolatramyl is and what it is used for

Dolatramyl contains tramadol hydrochloride. Tramadol hydrochloride is a painkiller that belongs to the group of opioids that act on the central nervous system. Dolatramyl relieves pain by affecting specific nerve cells in the spinal cord and brain.

Dolatramyl is used to treat moderate to severe pain in adults and adolescents over 12 years of age.

Tramadol hydrochloride contained in Dolatramyl may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Dolatramyl

Do not take Dolatramyl:

  • if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue.
  • if you have drunk too much alcohol or taken too many sleeping pills, painkillers, opiates, or other psychotropic drugs (medicines that affect your mood or your emotional state)
  • if you are taking certain monoamine oxidase inhibitors (medicines used to treat depression or Parkinson’s disease ) or if you have used such medicines in the last 14 days before treatment with Dolatramyl.
  • If you suffer from epilepsy and your seizures are not well controlled by medication.
  • as a treatment for withdrawal symptoms during drug withdrawal.

Warnings and cautions

Talk to your doctor or pharmacist before taking Dolatramyl if you:

  • think you are addicted to other painkillers ( opioids )
  • has a condition with increased pressure in the brain that causes symptoms such as headaches and vomiting (may occur after a head injury or with certain brain injuries)
  • has any effect on your consciousness (for example if you feel that you will faint)
  • is in a state of shock (cold sweats may be a sign of it)
  • have difficulty breathing
  • tend to get epilepsy or seizures because the risk of seizures may increase.
  • suffers from kidney or liver disease

Contact your doctor before taking the medicine if any of the above apply to you or have been done before.

Tramadol is converted into 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.

During treatment

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

Note that Dolatramyl may cause physical and mental dependence. When Dolatramyl is taken for a longer period of time, the effect may decrease and higher doses may be necessary ( tolerance development ). Patients with a tendency to drug abuse or drug dependence should only be treated with Dolatramyl for short periods and under strict medical supervision. Also, tell your doctor if any of these problems develop while you are taking Dolatramyl and if you have had any such problems before.

Children and young people

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

Other medicines and Dolatramyl

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Dolatramyl at the same time as or within 14 days of taking medicines called monoamine oxidase inhibitors (eg moclobemide or phenelzine for depression, selegiline for Parkinson’s disease ).

The analgesic effect of Dolatramyl may be weakened or shortened if you also take medicines containing:

  • carbamazepine (used to treat epilepsy )
  • other opioids (eg buprenorphine, nalbuphine, or pentazocine (painkillers))
  • ondansetron (used to treat nausea)

The risk of side effects increases if you take:

  • sedatives, hypnotics, other painkillers such as morphine and codeine (including cough medicines), and alcohol while taking this medicine. You may feel very drowsy or faint. Tell your doctor if this happens.
  • drugs that can cause seizures (seizures), such as certain antidepressants (eg selective serotonin reuptake inhibitors ( SSRIs ), serotonin noradrenaline reuptake inhibitors ( SNRIs ), tricyclic antidepressants ), or antipsychotic drugs. The risk of having a seizure may increase if you take Dolatramyl at the same time. Your doctor will tell you if Dolatramyl is right for you.
  • certain antidepressants (eg selective serotonin reuptake inhibitors ( SSRIs ), serotonin noradrenaline reuptake inhibitors ( SNRIs ), tricyclic antidepressants ). Dolatramyl may affect these medicines and you may experience symptoms such as involuntary, rhythmic contractions of muscles including the muscles that control eye movements, anxiety, severe sweating, tremors, excessive reflexes, increased muscle tension, and body temperature above 38 ° C.
  • coumarin anticoagulants (blood thinners) such as warfarin concomitantly with Dolatramyl. The effect of these medicines on the blood’s ability to coagulate can be affected and bleeding may occur.

Concomitant use of Dolatramyl with sedatives or medicines for sleep disorders such as benzodiazepines or similar medicines increases the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and may be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible.

If your doctor prescribes Dolatramyl 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 sedatives 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.

Dolatramyl with food, drink, and alcohol

Do not drink alcohol during treatment with Dolatramyl as the effect of the tablets may be enhanced. Food does not affect the effect of Dolatramyl.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Information on the safety of tramadol in the treatment of pregnant women is limited. Therefore, you should not use Dolatramyl if you are pregnant. Long-term treatment during pregnancy can lead to the newborn developing withdrawal symptoms.

Tramadol is excreted in human milk. Therefore, you should not take Dolatramyl more than once during breast-feeding. Alternatively, if you take Dolatramyl more than once, you should stop breast-feeding.

Based on human experience, tramadol hydrochloride is not thought to affect female or male fertility.

Driving and using machines

Dolatramyl may cause drowsiness, dizziness, and blurred vision, which may impair your ability to react. Do not drive or use any power tools or machines if you feel that the medicine is affecting you.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.

Dolatramyl contains lactose

Dolatramyl contains lactose, a certain sugar. 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 Dolatramyl

Dosage

Always take this medicine exactly as your doctor or pharmacist 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.

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

Adults and adolescents over 12 years:

Dolatramyl 100 mg prolonged-release tablets: one tablet (100 mg tramadol hydrochloride) twice daily, preferably in the morning and evening.

If this does not provide sufficient pain relief, the dose may be increased to:

Dolatramyl 150 mg prolonged-release tablets: one tablet (150 mg tramadol hydrochloride) twice daily, preferably in the morning and evening.

or:

Dolatramyl 200 mg prolonged-release tablets: one tablet (200 mg tramadol hydrochloride) twice daily, preferably in the morning and evening.

Your doctor may, if necessary, prescribe another more appropriate dose of Dolatramyl.

Do not take more than a total of 400 mg tramadol hydrochloride daily unless your doctor tells you to.

Use for children

Do not give Dolatramyl to children under 12 years of age.

Elderly patients

For elderly patients (over 75 years), it may take longer for tramadol hydrochloride to disappear from the body. If this affects you, your doctor may recommend that you prolong the time between doses.

Severe liver or kidney failure/dialysis patients

Patients with severe hepatic and/or renal failure should not take Dolatramyl. If you have mild or moderate liver and/or kidney failure, your doctor may recommend prolonging the time between doses.

How to take Dolatramyl

Always swallow the tablet whole with a glass of water, preferably morning and evening. The tablets should not be broken, chewed, or crushed. The tablets can be taken on an empty stomach or during a meal.

Duration of treatment

Your doctor will tell you how long to use Dolatramyl. It depends on the cause of the pain. Do not use Dolatramyl for longer than necessary. If you need to be treated for a long period of time, your doctor will check at regular intervals if you should continue to take Dolatramyl and in what dose. Interruptions in treatment will be made if necessary. If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.

If you take more Dolatramyl than you should

If you (or anyone else) swallow several Dolatramyl tablets at the same time, you should contact your doctor or emergency department immediately. You may feel sick, may have very small pupils, feel dizzy due to a drop in blood pressure, lose consciousness, fall into a coma, have seizures (convulsions), or have severe breathing difficulties.

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

If you forget to take Dolatramyl

If you forget to take your tablets, the pain will probably return. Take your dose as soon as you remember unless it is almost time for the next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Dolatramyl

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).

If you stop or stop treatment with this medicine too soon, the pain is likely to return. If you wish to discontinue your treatment due to side effects, consult your doctor.

Generally, no side effects occur when treatment with Dolatramyl is stopped. However, it has happened, in rare cases, that people who have used Dolatramyl for a long time and abruptly stopped taking the drug have experienced discomfort. They may experience restlessness, anxiety, nervousness, and shakiness. They may become confused, hyperactive, have difficulty falling asleep, and experience gastrointestinal upset.

A few people may suffer from confusion, panic attacks, paranoia, hallucinations, altered perception of reality, or altered self-perception. They can also suffer from abnormal experiences such as. itching, tingling and numbness, and ringing in the ears ( tinnitus ).

If you experience any of these discomforts after stopping Dolatramyl consult 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, this medicine can cause side effects, although not everybody gets them.

Stop taking the medicine and contact a doctor or seek emergency care immediately if you experience any of the following:

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

  • an allergic reaction such as difficulty breathing, wheezing, or swelling of the skin
  • swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives and difficulty breathing
  • shock / sudden circulatory failure
  • seizures.

Other side effects:

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

  • dizziness
  • nausea

Common (may affect up to 1 in 10 people):

  • headache, drowsiness
  • malaise, constipation, dry mouth
  • fatigue
  • sweating

Uncommon (may affect up to 1 in 100 people):

  • effect on the heart and blood circulation (palpitations, rapid heartbeat, fainting, or collapse). These side effects can especially occur in patients in an upright position or during physical exertion.
  • nausea, stomach upset (eg feeling of pressure in the stomach, bloating), diarrhea
  • skin reactions (eg itching, rash)

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

  • slow heart rate, high blood pressure
  • slow breathing and shortness of breath ( dyspnoea )
  • changes in appetite, abnormal sensations (eg itching, tingling, numbness), tremors
  • muscle twitching, weak muscles, uncoordinated movements
  • fainting ( syncope )
  • speech difficulties
  • blurred vision, pupillary contraction; enlarged pupil er
  • difficulty or pain when urinating, less urine than normal
  • hallucinations (seeing, feeling, or hearing things that do not exist), confusion, sleep disturbances, anxiety, disturbances of attention and emotional life ( delirium ) – and nightmares

Mental side effects can occur after treatment with Dolatramyl and these vary individually in intensity and nature (depending on the patient’s personality and duration of treatment). They may include mood swings (usually elation, sometimes irritation), changes in activity (usually decreased but sometimes increased activity), and decreased comprehension as well as decreased ability to make decisions, which can lead to errors in judgment. Drug dependence can occur.

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

  • dizziness or feeling that it is spinning (balance problems ( vertigo ))
  • flammable on the face and often also on other parts of the skin (swelling)
  • increase in liver enzyme values

No known frequency (cannot be calculated from the available data):

  • low blood sugar (hypoglycemia)
  • worsening of asthma even if it has not been confirmed to be caused by tramadol hydrochloride

If the recommended doses are exceeded, or if other drugs that inhibit brain function are taken at the same time, breathing may be slower.

If treatment is stopped or stopped abruptly, withdrawal symptoms may occur (see “If you stop taking Dolatramyl”).

5. How to store Dolatramyl

Keep this medicine out of the sight and reach of children.

No special storage instructions.

Do not use this medicine if you notice that the tablets discolor or show any other signs of deterioration. Contact a pharmacist who will tell you what to do.

Do not use this medicine after the expiry date which is stated on the blister card or jar after “EXP”. 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. Each prolonged-release tabletcontains:100 mg, 150 mg, or 200 mg of the active substance.
  • The other ingredients are microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate
  • The film coating of the tablet contains the following: hypromellose, lactose monohydrate, talc, macrogol, propylene glycol, titanium dioxide. Dolatramyl 150 mg and 200 mg prolonged-release tablets also contain red iron oxide (E172) and quinoline yellow (E104). Dolatramyl 100 mg prolonged-release tablets also contain brown iron oxide (E172).

What the medicine looks like and the contents of the pack

Dolatramyl 100 mg prolonged-release tablets are white to off-white, round, film-coated tablets, marked with “M” on one side and “TM1” on the other side.

Dolatramyl 150 mg prolonged-release tablets are bright orange, oval, film-coated tablets, marked with “M” on one side and “TM2” on the other side.

Dolatramyl 200 mg prolonged-release tablets are brownish-orange, capsule-shaped, film-coated tablets, marked with “M” on one side and “TM3” on the other side.

Dolatramyl prolonged-release tablets are packed in:

  • blisters delivered in cartons containing 10, 20, 20×1, 28, 30, 50, 56, 60, 60×1, 90 and 100 prolonged-release tablets .
  • HDPE cans with child-resistant closure in polypropylene containing 100 prolonged-release tablets.
  • HDPE cans with screw caps in polypropylene containing 500 and 1000 prolonged-release tablets (intended for dose dispensing)

Not all pack sizes may be marketed.

Manufacturer

McDermott Laboratories Limited trading as Gerard Laboratories, Ireland

or

Generics (UK) Ltd, United Kingdom

or

Mylan Hungary Kft., H-2900, Komárom, Mylan utca 1, Hungary

Muhammad Nadeem

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