5 mg, 10 mg, 30 mg, 60 mg, 100 mg, 200 mg prolonged-release tablet is 
morphine sulphate pentahydrate

1. What Dolcontin is and what it is used for

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

2. What you need to know before you use Dolcontin

Do not use Dolcontin

  • 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 infections 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.

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 and contact a 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:

  • 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 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 may lead to addiction. Proper use with prolonged, severe pain reduces the risk of addiction.

If you drink alcohol while taking Dolcontin, 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.

Other medicines and Dolcontin

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 and sedatives or antiepileptic drugs 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 with sedatives, your doctor should limit the dose and 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 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 can begin.

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.

Pregnancy

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

Breast-feeding

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

Driving and using machines

During treatment with Dolcontin, 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.

Dolcontin contains lactose

Dolcontin prolonged-release tablets 5 mg, 10 mg, 30 mg and 60 mg contain lactose . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Dolcontin

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 tablets should be swallowed whole.

If you take more Dolcontin than 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 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

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

If you stop using Dolcontin

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

Do not stop treatment with Dolcontin unless you have agreed to do so with your doctor. If you want to stop treatment with Dolcontin, ask your doctor how to lower the 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 and contact a 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
  • Armored
  • Spasm of ureter
  • Bile and urinary tract spasms
  • Taste changes
  • Mood swings
  • Feeling of excitement
  • Restlessness
  • Depression
  • A 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 the 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).

5. How to store Dolcontin

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 5 mg, 10 mg, 30 mg, 60 mg, 100 mg, and 200 mg, respectively, corresponding to morphine 3.75 mg, 7.5 mg, 22.5 mg, 45 mg, 75 mg, and 150 mg, respectively.
  • The other ingredients are lactose, anhydrous (95 mg prolonged-release tablet 5 mg, 90 mg prolonged-release tablet 10 mg, 70 mg prolonged-release tablet 30 mg, 40 mg prolonged-release tablet 60 mg), cetostearyl alcohol, hydroxyethylcellulose, talc, magnesium stearate, hypromellose, polyethylene glycol, dye ( titanium dioxide E 171).

Other dyes:

Iron oxide E 172 (5 mg, 30 mg, 60 mg, 100 mg)

Brilliant blue FCF E 133 (200 mg)

Quinoline yellow E 104 (200 mg)

What the medicine looks like and the contents of the pack

Dolcontin prolonged-release tablets have the following appearance:

5 mg: olive green, cupped tablets with a diameter of 7.3 mm, labeled DM.

10 mg: white, cupped tablets with a diameter of 7.3 mm, marked DO.

30 mg: yellow, cup-shaped tablets with a diameter of 7.3 mm, marked DL.

60 mg: pink, cupped tablets with a diameter of 7.3 mm, marked DZ.

100 mg: brown, cup-shaped tablets with a diameter of 7.3 mm, marked DU.

200 mg: blue-green, cupped tablets with a diameter of 8.8 mm, marked 200 mg.

Dolcontin prolonged-release tablets are provided in:

Printed packs of 25 and 100 tablets

Single-dose packs of 49 x 1 tablets.

Printable packs of 30 and 90 tablets.

Not all pack sizes and strengths 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

Fidelio Healthcare Limburg GmbH

Mundipharmastrasse 2, Limburg, Hessen 65549

Germany

or

Mundipharma DC BV

Leusderend 16, Leusden 3832RC

Netherlands

Muhammad Nadeem

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