30 mg, 60 mg, 90 mg, 120 mg, 150 mg, 200 mg hard 
prolonged-release capsules morphine sulphate pentahydrate

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 Dolcontin Unotard is and what it is used for 
2. What you need to know before you use Dolcontin Unotard 
3. How to use Dolcontin Unotard 
4. Possible side effects 
5. How to store Dolcontin Unotard 
6. Contents of the pack and other information 

What Dolcontin Unotard is and what it is used for

Morphine has a strong analgesic effect. Dolcontin Unotard is used for severe pain such as cancer pain.

What you need to know before using Dolcontin Unotard

Do not use Dolcontin Unotard

  • if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
  • at
  • impaired respiratory function
  • head injury
  • intestinal upset, severe abdominal pain, constipation
  • acute liver disease
  • cramps
  • chronic respiratory diseases such as asthma
  • anxiety disorder under the influence of alcohol and sleeping pills

Warnings and cautions

Talk to your doctor or pharmacist before using Dolcontin Unotard.

Tell your doctor if you have:

  • impaired thyroid function
  • impaired liver or kidney function
  • increased pressure in the skull
  • low blood pressure due to a reduced blood volume
  • the disease of the bile ducts or urinary tract
  • inflammation of the pancreas ( pancreatitis )
  • inflammatory bowel disease
  • the condition with a lot of mucus in the airways
  • enlarged prostate
  • impaired adrenal cortex function

If a total blockage in the bowel occurs, treatment should be discontinued. However, always consult your doctor before changing the medication.

Stop taking Dolcontin Unotard and contact your doctor immediately if you get any of the following symptoms ( anaphylactic reaction ):

• swelling of the face, tongue, or throat

• difficulty swallowing

• hives and difficulty breathing

Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Dolcontin Unotard:

  • Increased pain sensitivity even though you are taking increased doses(hyperalgesia). Your doctor will decide if you need to change the dose or switch to another strong analgesic (painkiller), (see section 2).
  • Weakness, fatigue, loss of appetite, nausea, vomiting, or low blood pressure. This may be a symptom that the adrenal glands are producing too little of the hormone et cortisol, and you may therefore need to take hormone supplements.
  • Loss of libido, impotence, missed periods. This may be due to decreased production of sex hormones.
  • If you have once been addicted to drugs or alcohol. Also, tell us if you feel you are becoming addicted to Dolcontin Unotard while using it. You may have started thinking a lot about when you can take the next dose, even if you do not need it for the pain.
  • Withdrawal symptoms or addiction. The most common withdrawal symptoms are mentioned in section 3. If this happens, your doctor may change the type of medicine or the times between doses.

The effects of Dolcontin Unotard may lead to addiction. Proper use with prolonged, severe pain reduces the risk of addiction.

If you drink alcohol while taking Dolcontin Unotard, 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 Dolcontin Unotard.

Other medicines and Dolcontin Unotard

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

You must tell your doctor or pharmacist if you are taking:

  • rifampicin to e.g. treat tuberculosis
  • other strong painkillers (opioids)
  • sedatives, hypnotics (eg benzodiazepines )
  • anesthetics for anesthesia before e.g. an operation
  • certain medicines for mental illness
  • muscle relaxants
  • certain antidepressants (clomipramine, amitriptyline)
  • certain hydrochloric acid inhibitors (cimetidine, for example for stomach ulcers )
  • medicines for high blood pressure
  • combined morphine agonists / antagonists (buprenorphine, nalbuphine, pentazocine)
  • Some medicines used to prevent blood clots (eg clopidogrel, prasugrel, ticagrelor) may have a delayed or reduced effect when taken with morphine.

Concomitant use of Dolcontin Unotard with sedatives or sleeping pills such as benzodiazepines or related drugs increases the risk of drowsiness, difficulty breathing ( respiratory depression ), and coma, and may be life-threatening. Concomitant use should therefore only be considered when other treatment options are lacking. However, if your doctor prescribes Dolcontin Unotard together with sedative drugs, your doctor should limit the dose and the duration of concomitant treatment. Tell your doctor about all sedative medicines you are taking, and carefully follow your doctor’s dose recommendation. It may be helpful to ask friends or relatives to be aware of the signs and symptoms mentioned above. Contact a doctor when you experience such symptoms.

Avoid concomitant treatment with Dolcontin Unotard and:

  • barbiturates (mainly used for anesthesia and severe epileptic seizures) as the combination impairs respiratory function
  • MAO inhibitors, e.g. selegiline and rasagiline (used in Parkinson’s disease ) and moclobemide (used in depression). If you have been treated with MAOIs, two weeks must pass before treatment with Dolcontin Unotard can begin.

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.

Pregnancy

There is a risk that the fetus is affected. Dolcontin Unotard should therefore not be used during pregnancy. Always consult a doctor before using Dolcontin Unotard during pregnancy. With long-term use of Dolcontin Unotard during pregnancy, there is a risk that the newborn baby will develop drug-withdrawal symptoms ( abstinence ) that will need to be treated by a doctor.

Breast-feeding

Morphine passes into breast milk. Dolcontin Unotard should therefore not be used during breast-feeding. Always consult a doctor before using Dolcontin Unotard when breast-feeding.

Driving and using machines

During treatment with Dolcontin Unotard, the ability to react may be reduced. This should be taken into account when sharper attention is required, e.g. when driving and using machines.

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

3. How to use Dolcontin Unotard

Always use this medicine exactly as your doctor has told you. Always follow your doctor’s prescription and the instructions on the pharmacy label. Ask your doctor or pharmacist if you are unsure.

Dose one is determined by the doctor, who adjusts it individually for you.

The capsules are swallowed whole or divided. The contents are then swallowed with a glass of water or sprinkled with suitable food, e.g. film milk, porridge, or ice cream. Note that the granules are specially designed to give an even and long-lasting effect and must therefore not be crushed or chewed.

Note that the medicine must be taken immediately after mixing it with

water or food.

If you use more Dolcontin Unotard then you should  

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

In case of overdose, the following symptoms may occur:

  • pneumonia by pulling down vomit or foreign matter in the lungs, with symptoms such as shortness of breath, cough, and fever
  • difficulty breathing leading to unconsciousness or even death
  • pupil reduction (pin-sized pupils ) 
  • low blood pressure.

Circulatory disorders and coma can occur in severe cases.

If you forget to use Dolcontin Unotard

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

If you stop using Dolcontin Unotard

If long-term treatment with Dolcontin Unotard is abruptly discontinued, withdrawal symptoms often occur.

Do not stop treatment with Dolcontin Unotard unless you have agreed to do so with your doctor. If you want to stop treatment with Dolcontin Unotard, ask your doctor how to lower your dose slowly to avoid withdrawal symptoms. Withdrawal symptoms can include body aches, tremors, diarrhea, abdominal pain, nausea, flu-like symptoms, palpitations, and enlarged pupils. Psychological symptoms include an intense feeling of dissatisfaction, anxiety/worry, and irritability.

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.

Important signs and symptoms to be observant of and what to do if you are affected:

  • The severe allergic reaction causes difficulty breathing or dizziness.

If you get this side effect, talk to your doctor immediately.

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

Stop taking Dolcontin Unotard and contact your doctor immediately if you get any of the following symptoms:

  • Seizures – Uncommon (affects less than 1 user in 100)
  • Abdominal pain ( colic ) – Uncommon (affects less than 1 user in 100)
  • Hallucinations or dizziness – Uncommon (affects less than 1 user in 100)
  • Hypersensitivity reaction with fever, rash, swelling, and sometimes drop in blood pressure – Rare (affects less than 1 user in 1,000)
  • Fainting –  Rare (affects less than 1 user in 1,000)

Other side effects ar

Common (affects more than 1 user in 100):

  • Headache
  • Drowsiness, which usually subsides after a few days
  • Involuntary muscle contractions
  • Respiratory cramps
  • Subdued cough reflex
  • Abdominal pain
  • Reduced appetite
  • Constipation
  • The feeling of discomfort in the upper abdomen
  • Nausea and vomiting, which usually subside after a period of medication
  • Difficulty throwing water
  • Dry mouth
  • Sweating
  • Rash
  • Itching
  • Insomnia
  • Impotence
  • Disorientation

Uncommon (affects less than 1 user in 100): 

  • Impaired respiratory function
  • Blush
  • Palpitation
  • Dizziness
  • Muscle tension
  • Emotional disorders
  • Pupil reduction
  • Pulmonary edema
  • Tarmvred
  • Spasm of ureter
  • Bile and urinary tract spasms
  • Taste changes
  • Mood swings
  • Feeling of excitement
  • Restlessness
  • Depression
  • The diffuse feeling of discomfort
  • Absence of menstruation
  • Decreased sex drive
  • Impotence
  • Elevated liver values

Rare (affects less than 1 user in 1,000):

  • Hives
  • Lowered blood pressure and heart rate
  • Fluid accumulation
  • Dimsyn
  • Double vision
  • Asthma attacks in sensitive people

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

  • Withdrawal syndrome in newborns
  • Increased pain sensitivity
  • Withdrawal symptoms or addiction (for symptoms, see section 3: If you stop using Dolcontin Unotard).

5. How to store Dolcontin Unotard

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

Do not store above 25 ° C.

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 sulfate pentahydrate 30 mg, 60 mg, 90 mg, 120 mg, 150 mg, and 200 mg, respectively, corresponding to morphine 22.5 mg, 45 mg, 67.5 mg, 90 mg, 112.5 mg, and 150 mg, respectively.
  • Other ingredients are:Tablet core: Saturated vegetable fat, polyethylene glycol 6000, talc, magnesium stearate.Capsule shell: Gelatin (containing sodium dodecyl sulphate)Dyes:  30 mg : E132, E171, 60 mg : E172, E132, E171, 90 mg : E127, E172, E171, 120 mg : E132, E172, E171, 150 mg : E127, E172, E132, E171, 200 mg : E172, E171.Capsule writing: Shellack, black iron oxide (dye E172), propylene glycol.

What the medicine looks like and the contents of the pack

Dolcontin Unotard prolonged-release capsules have the following appearance:

30 mg: light blue capsules labeled MS-OD 30.

60 mg: brown capsules labeled MS-OD 60.

90 mg: pink capsules labeled MS-OD 90.

120 mg: olive green capsules labeled MS-OD 120.

150 mg: blue capsules labeled MS-OD 150.

200 mg: stainless steel capsules labeled MS-OD 200.

Dolcontin Unotard prolonged-release capsules are supplied in blister packs of 28 prolonged-release capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Pfizer AB

191 90 Sollentuna

Phone: 08-550 520 00

Email: eumedinfo@pfizer.com

Manufacturer

Bard Pharmaceuticals Ltd

Cambridge, United Kingdom

or

Mundipharma DC BV

Leusderend 16, Leusden 3832RC

Netherlands

Muhammad Nadeem

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