10 mg, 30 mg, 60 mg 100 mg and 200 mg prolonged-release tablets are 
morphine hydrochloride trihydrate

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Depolan is and what it is used for 
2. What you need to know before using Depolan 
3. How to use Depolan 
4. Possible side effects 
5. How to store Depolan 
6. Contents of the pack and other ingredients information

1. What Depolan is and what it is used for

Depolan is a very strong and effective painkiller. It is used for long-term relief of severe and very severe persistent pain when other analgesics do not provide sufficient effect. It should not be used to treat mild pain.

The active substance in the Depolan prolonged-release tablet is released at a steady rate over a long period of time. The analgesic effect is delayed, therefore Depolan tablets can be taken at 12 hour intervals.

Morphine hydrochloride trihydrate contained in Depolan may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 using Depolan

Do not use Depolan

  • if you are allergic to morphine or any of the other ingredients of this medicine (listed in section 6)
  • if you suffer from a respiratory illness or have difficulty breathing due to other causes
  • if you have a lot of mucus in the airways
  • if you have cramps or head injuries
  • if you have an intestinal obstruction (obstruction in the intestinal passage)
  • in case of sudden abdominal pain or if you have indigestion (delayed bowel movements)
  • if you have liver disease
  • if you are also taking a so-called MAO inhibitor (certain antidepressants) or if you have taken such medicines in the last two weeks
  • if you have drunk alcohol or taken sleeping pills

Depolan must not be given to children under 1 year of age.

Warnings and cautions

Talk to your doctor or pharmacist before taking Depolan.

Depolan must be used with caution if you

  • is or has been addicted to opioids (certain painkillers such as morphine)
  • has increased pressure in the skull or low blood pressure
  • suffers from disturbances of consciousness
  • have any disease of the bile ducts or spasm of the bile ducts or ureters
  • have inflammation of the pancreas or intestines
  • has an enlarged prostate gland
  • has impaired adrenal cortex function (eg Addison’s disease )

If bowel movements are suspected or detected (paralytic ileus ), treatment with Depolan must be stopped immediately.

If you drink alcohol while taking Depolan prolonged-release tablets , it may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with a risk of respiratory arrest and unconsciousness. You should not drink alcohol while taking Depolan prolonged-release tablets .

If you abuse Depolan or if you take it for a long period of time, addiction can develop.

Withdrawal symptoms may occur if you suddenly stop taking Depolan (see section 3 If you stop taking Depolan).

Your doctor will prescribe a lower dose if you are older than 65 years, if you have impaired thyroid function or if you have severe liver or kidney function.

If you are a man of childbearing potential or a woman of childbearing potential , you should take Depolan only if the use of an effective method of contraception can be ensured (see Pregnancy and breast-feeding).

The film-coated tablets must not be dissolved and injected. The ingredients can in such cases cause local tissue death and granulomas in the lungs. Improper use can also lead to other harmful effects with potentially fatal outcome.

Other medicines and Depolan

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

Concomitant use of Depolan and other medicines may lead to the medicines increasing or decreasing each other’s effect.

Depolan enhances certain effects on the nervous system, such as drowsiness and respiratory depression (breathing problems), with the following medicines:

  • anesthetics (for dental surgery and general surgery )
  • sedatives and hypnotics
  • certain remedies for mental illness (eg for depression or psychosis )
  • certain remedies for vomiting and nausea
  • certain anti- allergy drugs
  • other strong painkillers ( opioids )
  • alcohol

Depolan generally enhances the effect of:

  • anesthetic
  • sedatives and hypnotics
  • alcohol
  • muscle relaxants
  • antihypertensive agents

Taking Depolan together with other drugs that suppress the central nervous system(eg sleeping pills, sedatives, certain drugs for mental illness, benzodiazepines ) can lead to respiratory depression (respiratory problems) with possible fatal outcome. Therefore, you must talk to your doctor before taking Depolan with these medicines.

The following medicines may affect the effect of Depolan:

  • gastric acid neutralizing agent (antacid); after taking one of these medicines, the other medicine should be taken at least 2 hours later
  • cimetidine (a medicine that inhibits gastric acid secretion)
  • monoamine oxidase (MAO) inhibitors (certain antidepressants)
  • rifampicin (anti- tuberculosis drug )
  • clomipramine and amitriptyline (certain antidepressants)

Depolan must not be combined with other morphine-like analgesics (eg buprenorphine, nalbufine, pentazocine).

Use of Deopolan with food, drink and alcohol

Depolan can be taken with or without food.

During treatment with Depolan, you should avoid drinking alcohol as alcohol can enhance its effect. Taking high doses of Depolan together with alcohol can lead to fatal side effects .

Pregnancy and breastfeeding

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.

Depolan should not be used during pregnancy.

The use of Depolan as pain relief during childbirth is not recommended due to the risk of respiratory depression in the newborn baby. If women are treated with Depolan during pregnancy, the newborn baby may develop withdrawal symptoms.

The use of Depolan during breast-feeding is not recommended as the active substance morphine is excreted in human milk.

Driving and using machines

This medicine may reduce your ability to react and impair your ability to drive.

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.

Depolan contains lactose and dyes

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

60 mg and 100 mg prolonged-release tablets contain the dye para-orange (E 110).

200 mg prolonged-release tablets contain the dyes para-orange (E 110) and neocockin (E 124).

These dyes can cause allergic reactions including asthma .

3. How to use Depolan

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

Swallow the tablets whole with a sufficient amount of liquid (eg a glass of water). The prolonged-release tablets must not be split, crushed or dissolved as the prolonged-release function of the tablet may be destroyed, which could lead to serious side effects .

Dosage

Dosage one of Depolan depends on the intensity of the pain, your age and your medical history. The doctor adjusts the dose to your needs. The appropriate dose will control your pain for 12 hours without causing any side effects or with only tolerable side effects . Your doctor will decide how long you should be treated.

For optimal dosing , Depolan is available in strengths of 10 mg, 30 mg, 60 mg, 100 mg and 200 mg.

Do not change the self-prescribed dosage . Contact your doctor if you think the effect of Depolan is too strong or too weak.

Use for children

Depolan is not recommended for children under 12 years of age due to limited experience.

Depolan must not be given to children under 1 year of age.

Adults and young people over 12 years

Initially 1-3 Depolan 10 mg prolonged-release tablets (equivalent to 10-30 mg morphine hydrochloride trihydrate) twice daily (morning and evening). Stick to the dosing interval (12 hours).

If the pain intensity increases or if tolerance to morphine develops, the doctor will increase the dose one.

Depolan 60 mg / 100 mg / 200 mg prolonged-release tablets are not suitable for initial treatment.

Elderly patients and patients with renal or hepatic impairment

Your doctor will prescribe a lower starting dose.

If you take more Depolan than you should

Respiratory depression poses a significant risk in case of an overdose of Depolan. Contact a doctor immediately if you have taken too many tablets. In case of overdose, the following symptoms may occur: pupil reduction, weak breathing which may lead to respiratory arrest, decreased blood pressure , circulatory disorders, shock and unconsciousness. Contact a doctor immediately if you suspect that a child has accidentally ingested the medicine – do not wait until you notice symptoms.

If you have ingested too much medicine or if, for example, a child has accidentally ingested medicine, contact a doctor, hospital or the Poison Information Center (tel. 112) for risk assessment and advice.

If you forget to take Depolan

Do not take a double dose to make up for a forgotten dose . Take your usual dose as soon as you notice that you forgot to take your dose . Take the next dose after 12 hours.

If you stop using Depolan

Withdrawal symptoms such as nausea, vomiting, tremors, dizziness, diarrhea, sweating or chills, cramps, rapid heartbeat and high blood pressure may occur if you suddenly stop taking Depolan.

Talk to your doctor if you want to stop taking Depolan.

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.

The following side effects may occur:

Common (may affect 1-10 of 100 users)

Contact your doctor if nausea, vomiting and / or constipation occur. Your doctor will prescribe a suitable medicine.

Uncommon (may affect 1-10 of 1,000 users)

  • palpitation
  • sweating, dizziness, headache, confusion, mood swings, overdose can lead to impaired respiratory function
  • respiratory cramps, impaired respiratory function
  • spasm of the gastrointestinal tract, dry mouth
  • problems with throwing water, cramps in the urinary tract
  • flushing
  • spasm of the bile ducts
  • hallucinations

Rare (may affect 1-10 of 10,000 users)

  • decreased or increased heart rate
  • blurred vision or double vision, involuntary eye movements
  • asthma attacks in sensitive patients
  • hives, itching
  • increased or decreased blood pressure
  • fluid accumulation in the tissues ( edema ), hypersensitivity reactions , general weakness which may lead to fainting, chills
  • insomnia

Very rare (may affect less than 1 in 10,000 users)

  • fluid accumulation in the lungs of patients in intensive care

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

  • cognitive impairment, muscle cramps

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Depolan

Do not store above 25 ° C.

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

Do not use this medicine after the expiry date which is stated on the carton 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 morphine hydrochloride trihydrate.

Depolan 10 mg: 1 prolonged-release tablet contains 10 mg morphine hydrochloride trihydrate equivalent to 7.59 mg morphine.

Depolan 30 mg: 1 prolonged-release tablet contains 30 mg morphine hydrochloride trihydrate equivalent to 22.78 mg morphine.

Depolan 60 mg: 1 prolonged-release tablet contains 60 mg of morphine hydrochloride trihydrate equivalent to 45.55 mg of morphine.

Depolan 100 mg: 1 prolonged-release tablet contains 100 mg of morphine hydrochloride trihydrate equivalent to 75.92 mg of morphine.

Depolan 200 mg: 1 prolonged-release tablet contains 200 mg of morphine hydrochloride trihydrate equivalent to 151.84 mg of morphine.

Other ingredients are:

Depolan 10 mg: lactose monohydrate , polyacrylate dispersion 30%, methacrylic acid-ethyl acrylate copolymer (1: 1), ammonium methacrylate copolymer type B, hypromellose 4000, colloidal anhydrous silica, magnesium stearate, macrogol 6000, talc, dye titanium dioxide (E 171), hypromellos 5.

Depolan 30 mg: lactose monohydrate , polyacrylate dispersion 30%, methacrylic acid-ethyl acrylate copolymer (1: 1), ammonium methacrylate copolymer type B, hypromellose 4000, magnesium stearate, macrogol 6000, talc, dye titanium dioxide (E 171), hypromellose 5, dyes indigo carmine (E 132) and quinoline yellow (E 104).

Depolan 60 mg: lactose monohydrate , polyacrylate dispersion 30%, methacrylic acid-ethyl acrylate copolymer (1: 1), ammonium methacrylate copolymer type B, hypromellose 4000, magnesium stearate, macrogol 6000, talc, dye titanium dioxide (E 171), hypromellose 5, dyes quinoline yellow (E 104) and para-orange (E 110).

Depolan 100 mg: lactose monohydrate , polyacrylate dispersion 30%, methacrylic acid-ethyl acrylate copolymer (1: 1), ammonium methacrylate copolymer type B, hypromellose 4000, magnesium stearate, macrogol 6000, talc, dye titanium dioxide (E 171), hypromellose 5, dyes quinoline yellow (E 104) and para-orange (E 110).

Depolan 200 mg: lactose monohydrate , polyacrylate dispersion 30%, methacrylic acid-ethyl acrylate copolymer (1: 1), ammonium methacrylate copolymer type B, hypromellose 4000, magnesium stearate, macrogol 6000, talc, hypromellose 5, dyes nycockin (E 124) and para -orange (E 110).

What the medicine looks like and contents of the pack

Depolan 10 mg: White, round and biconvex prolonged-release tablet .

Depolan 30 mg: Blue-green, round and biconvex prolonged-release tablet .

Depolan 60 mg: Yellow, round and biconvex prolonged-release tablet .

Depolan 100 mg: Yellow-orange, round and biconvex prolonged-release tablet .

Depolan 200 mg: Red, round and biconvex prolonged-release tablet .

Pack size: Cartons of 10, 14, 20, 30, 50, 60, 100 and 100×1 pcs.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

GL Pharma GmbH, 8502 Lannach, Austria

Representative in Sweden

Nordic Drugs AB, Box 300 35, 200 61 Limhamn

Muhammad Nadeem

Leave a Reply