Dropizol 10mg/ml oral drops

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• If you are allergic to opium or morphine or any of the other ingredients of this medicine (listed in section 6)
• If you have opiate dependency
• If you suffer from glaucoma (raised pressure in the eye)
• If you have severe liver or kidney disease
• If you have alcohol withdrawal symptoms (delirium tremens).
• If you have a severe head trauma
• If you are at risk of paralytic ileus (obstruction of the intestine due to paralysis of the intestinal muscles)
• If you suffer from acute asthma
• a chronic pulmonary disease that makes it hard to breathe (COPD)
• If you have breathing problems because of severe respiratory depression. Your doctor will have told you if you have any of these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected
• If you have heart failure secondary to lung disease (cor pulmonale)
• If you are breast-feeding

Talk to your doctor, pharmacist or nurse before taking Dropizol:

• If you are elderly, as elderly people may react differently to this medicine. The dose may need to be adjusted.
• If you have a chronic kidney and/or liver disease. The dose may need to be adjusted.
• If you are addicted to narcotics or alcohol
• If you have gallbladder disease or gallstones
• If you have a head injury or increased pressure in the brain
• If you have reduced consciousness
• If you are taking medication for depression (moclobemide or other MAO-inhibitors) or have stopped using this medication within the last 2 weeks
• If you have reduced adrenal glands function
• If you have underactive thyroid, the dose may need to be adjusted.
• Low blood pressure with decreased blood volume
• Inflammation of the pancreas
• If you have prostatic hyperplasia (enlargement of the prostate) and/or conditions predisposing to urinary retention.
• If you have an infection or inflammation of the intestines since inhibition of peristalsis may increase the risk of uptake of toxins and development of an enlarged colon and perforation of your intestines.
• If you suffer from epilepsy
• If you take other medicines against diarrhoea
• If you experience seizures
• If you have a bleeding in your stomach and/or intestines
• If you take medicine against increased blood pressure

If you experience difficulty to urinate a health care professional should be contacted.

Dropizol is not recommended before surgery or within 24 hours after operation due to risk of paralytic ileus. The symptoms of which are nausea and vomiting.

Risk for dependence and tolerance when using the product.

Tolerance, dependence, and addiction

This medicine contains morphine which is an opioid medicine. Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Dropizol can also lead to dependence, abuse, and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to Dropizol if:

• You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs whilst taking Dropizol, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than advised by your doctor
• You need to take more than the recommended dose
• You are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’
• You have made repeated, unsuccessful attempts to quit or control the use of the medicine
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (‘withdrawal effects’)

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop taking Dropizol).

Acute generalized exanthematous pustulosis (AGEP) has been reported in association with Dropizol treatment. Symptoms usually occur within the first 10 days of treatment. Tell your doctor if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Dropizol or other opioids. Stop using Dropizol and seek medical attention immediately, if you notice any of the following symptoms: blistering, widespread scaly skin or pus-filled spots together with fever.

Dropizol can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system.

Dropizol should not be used in children and adolescents aged below 18 years

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

It is especially important that you tell your doctor or pharmacist if you are taking:

• Medicines that potentiate the reduced consciousness and difficulty breathing, seen with Dropizol, such as
  • Alcohol
  • Sleeping medicines (e.g. zolpidem) and general anaesthetics (e.g. barbiturates)
  • Medicines to treat depression (Tricyclic antidepressants) or Parkinson’s disease (MAO-inhibitors, e.g. safinamide)
  • Antipsychotic medicines with a sedative action (e.g. phenothiazines)
  • Medicines to treat epilepsy and pain due to nerve problems (gabapentin or pregabalin)
  • Medicines to relieve nausea and vomiting (e.g. bromopride, meclizine, metoclopramide)
  • Medicines to relieve allergy (antihistamines, e.g. carbinoxamine, doxylamine)
  • Other opioid pain relievers (e.g. alfentanil, butorphanol, fentanyl, hydrocodone, hydromorphone, levorphanol, meperidine, methadone, oxycodone, oxymorphone, remifentanil, sufentanil, tapentadol, tramadol).
• Medicines that have a similar mode of action as morphine and therefore may increase withdrawal symptioms and reduce therapeutic effect (buprenorphine, nalbuphine, nalmefene, naltrexone, pentazocine)
• Medicines to treat alcohol abuse (disulfiram) or medicines to treat certain kinds of infections (metronidazole) as this might cause unpleasant side effects such as flushing, rapid breathing and fast heart rate
• Medicines to treat tuberculosis (rifampicin) decreases the effect of morphine
• Some medicines used to treat blood clots (e.g. clopidogrel, prasugrel, ticagrelor) may have delayed and decreased effect when taken together with opium
• Amphetamine and analogues can reduce the sedative effect of opioids.
• Loxapine and periciazine can increase the sedative effect of opioids.
• Concomitant use of flibanserin and opioids may increase the risk of CNS depression.
• Opioids can increase the plasma concentrations of desmopressin and sertraline
• Zidovudine (medicine to treat or prevent HIV infections).
• Medicines to treat depression (fluoxetine) might reduce the duration of action of morphine

Concomitant use of Dropizol and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Dropizol together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all sedative medicines you are taking and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor if you experience such symptoms.

Concurrent administration of morphine may increase the effects of drugs that decrease your blood pressure or other drugs with a lowering effect on your blood pressure.

Dropizol can be taken with food and drink. Dropizol contains alcohol, so extra care should be exercised when consuming alcohol.

See “Dropizol contains ethanol” below.

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

Do not take Dropizol during pregnancy unless your doctor has told you to. Dropizol should not be taken close to the date to give birth due to the risk of withdrawal symptoms in the neonate.

Breastfeeding

Dropizol must not be used during breastfeeding.

Fertility

It is unknown whether Morphine may harm your fertility. Fertile men and women should use effective contraception when using Dropizol.

Dropizol contains morphine and ethanol and it may cause drowsiness and significantly affect your ability to drive or operate machines.

Do not drive after taking your medicines until you know how they affect you.

This medicinal product contains 33 vol % ethanol (alcohol), i.e. up to 260 mg per dose, equivalent to 6.6 ml of beer or 2.8 ml of wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

Dropizol should not be used in children and adolescents below 18 years.

If you take too much Dropizol you may experience small pupils, slow heartrates, low blood pressure, lung edema, breathing difficulties and depressed levels of consciousness which may lead to coma. Call your doctor if you have taken more Dropizol than your doctor has prescribed for you or as stated in this leaflet and you feel uncomfortable.

You should take the missed dose as soon as you remember, unless it is nearly time for the next dose.

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

Continue taking the medicine as long as your doctor has told you to.

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

Drowsiness and constipation, dry mouth

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

Dizziness, headache, pupil contraction, nausea and vomiting, loss of appetite, indigestion or discomfort, changes in taste and smell, urticaria, sweating, bronchospasm, decreased coughing, asthenia

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

Facial flushing, itching, spasms in the lower urinary tract, abnormal liver tests

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

Increase in pancreatic enzymes (seen in a blood test) and inflammation of the pancreas, pain because of kidney stones (renal colic) or gallstones (biliary colic), withdrawal symptoms, orthostatic hypotension (a form of low blood pressure that happens when you stand up from sitting or lying down)

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

Difficulty breathing, muscle cramp, seizures, burning and stinging pain, increased sensitivity to pain, blurred vision, double vision, involuntary movement of the eye, a condition where the bowel does not work properly (ileus), abdominal pain, rash, swelling of the hands, ankles or feet, feeling unwell, shivering, syndrome of inappropriate antidiuretic hormone (SIADH) (symptoms: nausea, malaise, headache, exhaustion and in severe cases may progress to seizures and coma), absence of menstrual bleeding.

Not known (frequency cannot be estimated from the available data):

Adrenal insufficiency (fatigue, weight loss, fainting, low blood sugar, nausea, diarrhea, vomiting and abdominal pain), Euphoria (strong sense of well-being, happiness and excitement), uncontrolled muscle movements, addiction, dysphoric mood (sad, without energy), restlessness, decreased libido or potency, hallucinations, vertigo and fever. Sleep apnoea (breathing pauses during sleep). Symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system, e.g. severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever.

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 via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is: Opium tincture
• 1 ml of oral liquid contains 1 ml of tincture from Papaver somniferum L., succus siccus (Opium, raw) corresponding to 10 mg of morphine.
  1 drop contains 50 mg opium tincture equivalent to 0.5 mg (10 mg/ml) anhydrous morphine.
  1 ml contains 20 drops.
• Extraction solvent: 33 % ethanol (V/V)
• Excipients
• Ethanol 96% V/V
• Purified water

Dropizol is a dark, reddish brown liquid. It is available in a brown glass bottle with dropper and a child-resistant closure.

Pack sizes 1 x 10 ml, 3 x 10 ml, 4 x 10 ml, 5 x 10 ml and 10 x 10 ml.

Not all pack sizes may be marketed