Dropizol 10 mg/ml oral solution drops

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dropizol 10 mg/ml oral drops solution

Morphine in opium tincture

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Dropizol is and what it is used for

Dropizol is a herbal medicine containing morphine.

Dropizol belongs to a group of medicines called antipropulsives and is used in adults to treat symptoms of acute diarrhoea when other antidiarrhoeal treatments have not provided sufficient effect.

Dropizol works by inhibiting intestinal motility.

2. What you need to know before taking Dropizol

Do not take Dropizol:

• if you are allergic to opium or morphine or to any of the other components of this medicine (listed in section 6).
• if you have opioid dependence.
• if you have glaucoma (increased intraocular pressure).
• if you have severe liver or kidney disease.
• if you have symptoms of alcohol withdrawal (delirium tremens).
• if you have a severe head injury.
• if you are at risk of paralytic ileus (intestinal obstruction due to paralysis of intestinal muscles).
• if you have acute asthma.
• if you have chronic lung disease that makes breathing difficult (COPD).
• if you have respiratory problems due to severe respiratory depression. Your doctor will inform you if you have any of these conditions. Symptoms may include difficulty breathing, coughing, or slower or weaker breathing than expected.
• if you have pulmonary heart disease (cor pulmonale).
• if you are breastfeeding.

Warnings and precautions

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

• If you are elderly, as this group of patients may react differently to this medicine. A dose adjustment may be necessary.
• If you have chronic kidney or liver disease. A dose adjustment may be necessary.
• If you are addicted to sleeping pills or alcohol.
• If you have gallbladder disease or gallstones.
• If you have a head injury or increased intracranial pressure.
• If you have reduced level of consciousness.
• If you are taking medicines for depression (moclobemide or other MAO inhibitors) or have stopped taking such medicines within the last 2 weeks.
• If you have adrenal insufficiency.
• If you have hypothyroidism, a dose adjustment may be necessary.
• Hypotension associated with reduced blood volume.
• Pancreatic inflammation (pancreatitis).
• If you have benign prostatic hyperplasia (enlarged prostate) or conditions predisposing to urinary retention.
• If you have intestinal infection or inflammation, as inhibition of intestinal peristalsis could increase the risk of toxin absorption and lead to colonic hypertrophy and intestinal perforation.
• If you have epilepsy.
• If you are taking other medicines for diarrhea.
• If you have seizures.
• If you have gastric or duodenal bleeding.
• If you are taking medicines for high blood pressure.

If you experience difficulty urinating, contact a healthcare professional.

Dropizol is not recommended before surgery or within 24 hours after surgery due to the risk of paralytic ileus, whose symptoms include nausea and vomiting.

Risk of dependence and tolerance with use of the medicine

Tolerance, dependence, and addiction

This medicine contains morphine, which is an opioid medicine. Repeated use of opioids may make the medicine less effective (you become used to it, known as tolerance). Repeated use of Dropizol may also lead to dependence, abuse, and addiction, which could result in potentially fatal overdose. The risk of these side effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you no longer have control over how much medicine you take or how often you take it.

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

• You or a family member has ever abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have ever had mood problems (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 while taking Dropizol, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than your doctor recommended.
• You need to take higher doses than recommended.
• You are using the medicine for reasons other than those prescribed, for example, "to stay calm" or "to help you sleep."
• You have made repeated unsuccessful attempts to stop or control use of the medicine.
• When you stop taking the medicine, you feel unwell and feel better when you take it again ("withdrawal effects").

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

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

Sleep-related breathing disorders

Dropizol may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, waking up at night gasping for air, difficulty staying asleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing your dose.

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

Children and adolescents

Dropizol must not be used in children and adolescents under 18 years of age.

Taking Dropizol with other medicines

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

It is especially important to inform your doctor or pharmacist if you are taking any of the following medicines:

• Medicines that may enhance the reduction in consciousness and breathing difficulties observed with Dropizol use, such as:
  • Alcohol
  • Sleeping pills (e.g., zolpidem) and general anesthetics (e.g., barbiturates)
  • Medicines for depression (tricyclic antidepressants) or Parkinson's disease (MAO inhibitors, e.g., safinamide)
  • Antipsychotic medicines with sedative effects (e.g., phenothiazines)
  • Medicines for epilepsy and nerve-related pain (gabapentin or pregabalin)
  • Medicines to relieve nausea and vomiting (e.g., bromopride, meclizine, metoclopramide)
  • Medicines to relieve allergies (antihistamines, e.g., carbinoxamine, doxylamine)
  • Other opioid analgesics (e.g., alfentanil, butorphanol, fentanyl, hydrocodone, hydromorphone, levorphanol, meperidine, methadone, oxycodone, oxymorphone, remifentanil, sufentanil, tapentadol, tramadol)
• Medicines with a mechanism of action similar to morphine that may increase withdrawal symptoms and reduce therapeutic effect (buprenorphine, nalbuphine, nalmefene, naltrexone, pentazocine).
• Medicines for alcoholism (disulfiram) or medicines for certain infections (metronidazole), which may cause undesirable adverse effects such as flushing, rapid breathing, and fast heart rate.
• Medicines for tuberculosis (rifampicin) reduce the effect of morphine.
• Some medicines used to treat blood clots (e.g., clopidogrel, prasugrel, ticagrelor) may have delayed and reduced effects when taken with morphine.
• Amphetamines and analogs may reduce the sedative effect of opioids.
• Loxapine and periciazine may increase the sedative effect of opioids.
• Concurrent use of flibanserin and opioids may increase the risk of CNS depression.
• Opioids may increase plasma concentrations of desmopressin and sertraline.
• Zidovudine (a medicine to treat or prevent HIV infection).
• Medicines used to treat depression (fluoxetine) may reduce the duration of morphine's action.

Concurrent use of Dropizol and sedative medicines, such as benzodiazepines or related drugs, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and is potentially fatal. Therefore, concurrent use should only be considered when no other therapeutic options are possible.

However, if your doctor prescribes Dropizol together with sedative medicines, they will limit the dose and duration of concurrent treatment.

Inform your doctor about all sedative medicines you are taking and strictly follow the dosing recommendations provided by your doctor. It may help to inform your friends or family to be alert for the signs and symptoms described above. If you experience such symptoms, contact your doctor.

Concomitant administration of morphine may enhance the effects of medicines that lower blood pressure or other medicines affecting blood pressure.

Taking Dropizol with food, drinks, and alcohol

Dropizol may be taken with food and drinks. Dropizol contains alcohol, so caution is advised if consuming alcohol.

See the section Dropizol contains ethanol below.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy:

Dropizol should not be used during pregnancy unless prescribed by your doctor. Extreme caution should be exercised when using this medicine in pregnant women. Dropizol should not be used close to the expected date of delivery due to the risk of withdrawal symptoms in the newborn.

Breastfeeding:

Dropizol must not be used during breastfeeding.

Fertility

It is unknown whether morphine negatively affects fertility. Men and women of reproductive age should use effective contraception during treatment with Dropizol.

Driving and using machines

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

Do not drive after taking this medicine until you know how it affects you.

Dropizol contains ethanol

This medicine contains 33% ethanol by volume (alcohol), corresponding to 260 mg per dose, equivalent to 6.6 ml of beer or 2.8 ml of wine per dose. This medicine is harmful for people with alcoholism. The alcohol content should be taken into account in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.

3. How to take Dropizol

Follow exactly the instructions for use of this medicine as prescribed by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose in adults is:

Adults: 5-10 drops 2-3 times a day.

The single dose must not exceed 1 ml, and the total daily dose must not exceed 6 ml.

Elderly patients: the initial dosage regimen should be reduced.

Hepatic impairment: Dropizol should not be used, or the dosage regimen should be reduced. See the section Do not take Dropizol and Warnings and precautions in section 2.

Renal impairment: Dropizol should not be used, or the dosage regimen should be reduced. See the section Do not take Dropizol and Warnings and precautions in section 2.

Each milliliter contains approximately 20 drops.

Method of administration:

Oral use.

Dropizol can be used undiluted or mixed with a glass of water. After mixing with water, it should be taken immediately. If using Dropizol undiluted, the correct dose can be administered using a spoon.

1. Open the child-resistant cap: 2. Hold the bottle in an upright position

Press down and turn. and dispense drops onto a spoon or into a glass.

Use in children and adolescents

Dropizol must not be used in children and adolescents under 18 years of age.

If you take more Dropizol than you should

If you take too much Dropizol, you may experience constricted pupils, reduced heart rate, low blood pressure, pulmonary edema, breathing difficulties, and decreased level of consciousness, which could lead to coma.

Call your doctor if you have taken more Dropizol than prescribed, or if you take it as indicated in the leaflet and feel unwell.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Dropizol

Take the missed dose as soon as possible after you remember, unless it is almost time for your next dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Dropizol

Continue taking this medicine for the length of time prescribed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them. Stop using Dropizol and seek immediate medical attention if you notice any of the following symptoms.

Serious adverse effects

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

Difficulty urinating

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

Shortness of breath, fatigue, anxiety, bluish discoloration of the lips and fingers of the hands and feet, headache, confusion, seizures, and swelling of the legs and feet (respiratory depression).

Cardiac arrhythmia (fast or slow heart rate)

Frequency not known (cannot be estimated from available data):

Severe skin reaction with blisters, widespread peeling of the skin, pustules (pus-filled spots) together with fever. This could be a condition called acute generalized exanthematous pustulosis (AGEP).

Other adverse effects

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

Somnolence and constipation, dry mouth

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

Dizziness, headache, pupillary constriction, nausea and vomiting, loss of appetite, indigestion or discomfort, disturbances in taste and smell, urticaria, sweating, bronchospasm, reduced cough

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

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

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

Increased concentration of liver enzymes (observed in blood tests) and inflammation of the pancreas, pain due to kidney stones (renal colic) or gallstones (biliary colic), withdrawal symptoms, orthostatic hypotension (a type of low blood pressure occurring when standing up after sitting or lying down)

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

Breathing difficulty, muscle cramps, seizures, burning and itching, increased sensitivity to pain, blurred vision, double vision, involuntary eye movements, a condition in which the intestine does not function properly (ileus), abdominal pain, rash, swelling of the hands, ankles or feet, malaise, chills, syndrome of inappropriate antidiuretic hormone secretion (SIADH) (symptoms: nausea, malaise, headache, fatigue, and in severe cases, may progress to seizures and coma), amenorrhea.

Frequency not known (cannot be estimated from available data):

Adrenal insufficiency (fatigue, weight loss, fainting, hypoglycemia, nausea, diarrhea, vomiting and abdominal pain), euphoria (intense feeling of well-being, happiness and excitement), uncontrolled muscle movements, addiction, dysphoric state (sadness, lack of energy), restlessness, decreased libido or potency, hallucinations, vertigo and fever. Sleep apnea (pauses in breathing 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.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines at www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dropizol

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month indicated.

Do not refrigerate or freeze.

The bottle should be used within 4 weeks of first opening.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be taken to the SIGRE collection point at your pharmacy or to any other medicine waste collection system. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dropizol

• The active substance is: opium tincture

Each millilitre of oral solution contains 1 ml of tincture of Papaver somniferum(L.), Succus siccus (raw opium), equivalent to 10 mg of morphine.

Each drop contains 50 mg of opium tincture, equivalent to 0.5 mg (10 mg/ml) of anhydrous morphine.

Each millilitre contains 20 drops.

• Extraction solvent: 33% ethanol (v/v)
• The other components are:
• Ethanol 96% (v/v)
• Purified water

Appearance of the product and contents of the pack

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

Pack sizes: 1 × 10 ml, 2 × 10 ml, 3 × 10 ml, 4 × 10 ml, 5 × 10 ml and 10 × 10 ml.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Pharmanovia A/S

Ørestads Boulevard 108, 5

DK- 2300 København S

Denmark

Email: [email protected]

Manufacturer

Lomapharm GmBH

Langes Feld 5

D-31860 Emmerthal

Germany

Atnahs Pharma Denmark ApS

Copenhagen Towers,

Ørestads Boulevard 108, 5.tv,

DK-2300 København S,

Denmark

Misom Labs Limited

Malta Life Sciences Park,

LS2.01.06 Industrial Estate,

San Gwann, SGN 3000,

Malta

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

This medicinal product is authorized in the European Economic Area member states under the following names:

Denmark: Dropizol

Iceland: Dropizol

Finland: Dropizol

Norway: Dropizol

Sweden: Dropizol

UK: Dropizol

Austria: Dropizol

Belgium: Dropizole

Czech Republic: Dropizol

Germany: Dropizol

Spain: Dropizol

France: Dropizal

Hungary: Dropizol

Ireland: Dropizol

Italy: Dropizole

Luxembourg: Dropizol

Netherlands: Dropizol

Portugal: Dropizale

Romania: Dropizol

Slovak Republic: Dropizol

Date of latest review of this leaflet: June 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/