Leaflet: information for the patient

Dropizol 10 mg/ml oral drops in solution

Morphine in opium tincture

Read this 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, consult your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What is Dropizol and what it is used for

2.What you need to know before starting to take Dropizol

3.How to take Dropizol

4.Possible side effects

5.Storage of Dropizol

6.Contents of the pack and additional information

Dropizol is a plant-based medication that contains morphine.

Dropizol belongs to a group of medications known as antipropulsives and is used in adults to treat the symptoms of acute diarrhea when the use of other antidiarrheal treatments has not been sufficient.

Dropizol acts by inhibiting intestinal motility.

Do not take Dropizol:

-if you are allergic to opium or morphine or any of the other components of this medication (listed in section 6).

-if you have a dependence on opioids.

-if you have glaucoma (increased intraocular pressure).

-if you have a severe liver or kidney disease.

-If you have symptoms of alcohol withdrawal (delirium tremens).

-if you have a severe head trauma.

-if you have a risk of developing paralytic ileus (obstruction of the intestine by paralysis of the intestinal muscles).

-if you have acute asthma.

-if you have chronic lung disease that makes it difficult to breathe (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 secondary heart failure due to lung disease (cor pulmonale).

-if you are breastfeeding.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Dropizol:

•If you are an elderly patient, as this group of patients may react differently to this medication. The dose may need to be adjusted.

•If you have chronic kidney or liver disease. The dose may need to be adjusted.

•If you are addicted to sedatives or alcohol.

•If you have a gallbladder disease or gallstones.

•If you have a severe head trauma or increased intracranial pressure.

•If you have a reduced level of consciousness.

•If you are taking medications for depression (moclobemide or other MAO inhibitors) or have stopped taking this medication in the last 2 weeks.

•If you have adrenal gland insufficiency.

•If you have hypothyroidism, the dose may need to be adjusted.

•Hypotension, accompanied by reduced blood volume.

•Pancreatitis.

•If you have benign prostatic hyperplasia (enlargement of the prostate) or conditions that predispose to urinary retention.

•If you have an infection or inflammation of the intestine, as the inhibition of intestinal peristalsis could increase the risk of absorption of toxins and the development of colon hypertrophy and intestinal perforation.

•If you have epilepsy.

•If you are taking other medications for diarrhea.

•If you have seizures.

•If you have a gastric or duodenal hemorrhage.

•If you are taking medications for hypertension.

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 are nausea and vomiting.

Risk of dependence and tolerance with the use of the medication.

Tolerance, dependence, and addiction.

This medication contains morphine, which is an opioid medication. Repeated use of opioids can make the medication less effective (one becomes accustomed to it, known as tolerance). Repeated use of Dropizol can also cause dependence, abuse, and addiction, which can cause a potentially fatal overdose. The risk of these side effects may increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel like you no longer have control over the amount of medication you take or how often you take it.

The risk of becoming dependent or addicted to Dropizol 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 medications, or illegal drugs ("addiction").

- You are a smoker.

- You have ever had problems with your mood (depression, anxiety, or some 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 medication for a longer time than recommended by your doctor.

- You need to take more doses than recommended.

- You are using the medication 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 the use of the medication.

- When you stop taking the medication, you feel bad and feel better when you go back to taking the medication ("withdrawal symptoms").

If you notice any of these signs, talk to your doctor to analyze the best course of treatment for you, including when it is appropriate to discontinue it and how to do it safely (see section 3, If you stop taking Dropizol).

Children and adolescents

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

Generalized acute pustular psoriasis (GAP) has been reported in association with treatment with Dropizol. Symptoms usually appear within the first 10 days of treatment. Inform your doctor if you have ever developed a severe skin rash or skin peeling, blisters, 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: blisters, widespread scaly skin, or pus-filled spots with fever.

Respiratory disorders related to sleep

Dropizol can cause respiratory disorders related to sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to lack of air, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Inform your doctor if you experience severe upper abdominal pain that may radiate to the back, nausea, vomiting, or fever, as these may be symptoms associated with pancreatitis and the biliary tract system.

Use of Dropizol with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

•Medications that potentiate reduced consciousness and respiratory difficulty, observed with the use of Dropizol, such as:

-Alcohol

-Sedatives (e.g., zolpidem) and general anesthetics (e.g., barbiturates)

-Medications for depression (tricyclic antidepressants) or Parkinson's disease (MAO inhibitors, e.g., safinamide)

-Antipsychotics with sedative action (e.g., phenothiazines)

-Medications for epilepsy and pain due to nervous system problems (gabapentin or pregabalin)

-Medications to relieve nausea and vomiting (e.g., bromopride, meclozine, metoclopramide)

-Medications to relieve allergies (antihistamines, e.g., carbinoxamine, doxylamine)

-Other opioid analgesics (e.g., alfentanil, butorphanol, fentanyl, hydrocodone, hydromorphone, levorphanol, pentazocine, methadone, oxycodone, oxymorphone, remifentanil, sufentanil, tapentadol, tramadol)

•Medications with a mechanism of action similar to morphine and, therefore, that may increase withdrawal symptoms and reduce therapeutic effect (buprenorphine, nalbuphine, nalmefene, naltrexone, pentazocine).

•Medications for alcoholism (disulfiram) or medications for certain types of infections (metronidazole), as they may cause undesirable side effects, such as flushing, rapid breathing, and rapid heart rate.

•Rifampicin, used in the treatment of tuberculosis, reduces the effect of morphine.

•Some medications used in the treatment of blood clots (e.g., clopidogrel, prasugrel, ticagrelor) may have a delayed and reduced effect when taken with morphine.

•Amphetamine and analogs may reduce the sedative effect of opioids.

•Loxapine and periciazine may increase the sedative effect of opioids.

•The simultaneous use of flibanserin and opioids may increase the risk of CNS depression.

•Opioids may increase the plasma concentrations of desmopressin and sertraline.

•Zidovudine (a medication for treating or preventing HIV infections).

•Medications used to treat depression (fluoxetine) may reduce the duration of action of morphine.

The simultaneous use of Dropizol and sedatives, such as benzodiazepines or related drugs, increases the risk of somnolence, respiratory difficulty (respiratory depression), and coma and is potentially fatal. As a consequence, simultaneous use should only be considered when other therapeutic options are not possible.

However, if your doctor prescribes Dropizol along with sedatives, they will restrict the dose and duration of simultaneous treatment.

Inform your doctor of all sedatives you are taking and follow your doctor's recommended dosage strictly. It may be helpful to inform your friends or family members to be aware of the signs and symptoms described above. If you experience these symptoms, contact your doctor.

The simultaneous administration of morphine may increase the effects of medications that reduce blood pressure or other medications that affect blood pressure.

Use of Dropizol with food, drinks, and alcohol

Dropizol can be taken with meals and drinks. Dropizol contains alcohol, so caution should be exercised if alcohol is consumed.

See below the sectionDropizol contains ethanol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

Dropizol should not be used during pregnancy unless your doctor has indicated it. You should exercise extreme caution when using this medication in pregnant women. Dropizol should not be used near the time of delivery due to the risk of withdrawal symptoms in the newborn.

Breastfeeding:

Dropizol should not be used during breastfeeding.

Fertility:

The effect of morphine on fertility is unknown. Men and women of childbearing age should use effective contraceptive methods during treatment with Dropizol.

Driving and operating machinery

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

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

Dropizol contains ethanol

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of 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 should not exceed 1 ml, and the total daily dose should not exceed 6 ml.

Older patients: the initial dosage regimen should be reduced.

Liver insufficiency: Dropizol should not be used, or the dosage regimen should be reduced. See the sectionDo not take Dropizol and Warnings and Precautionsin section 2.

Renal insufficiency: Dropizol should not be used, or the dosage regimen should be reduced. See the sectionDo not take Dropizol and Warnings and Precautionsin section 2.

Each milliliter contains approximately 20 drops.

Administration form:

Oral route.

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

1. Open the child-resistant closure:2. Hold the bottle in a vertical position

Press down and turn.and drip onto a spoon or a glass.

Use in children and adolescents

Dropizol should 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, respiratory difficulties, and reduced level of consciousness, which could cause coma.

Call your doctor if you have taken more Dropizol than prescribed or if you take it as indicated on the package insert and feel uncomfortable.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you forget to take Dropizol

You should take the missed dose as soon as you remember it, unless it is almost time to take the next dose. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Dropizol

Continue taking the medication for the time your doctor has indicated.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

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

Severe side effects

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

Difficulty urinating

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

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

Arrhythmia (rapid or slow heart rate)

Other side effects

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 constriction, nausea and vomiting, loss of appetite, indigestion or discomfort, taste and smell alterations, urticaria, sweating, bronchospasm, decreased cough, asthenia

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

Facial flushing, itching, spasms in the lower urinary tract, liver function test alterations

Rare(may affect up to 1 in 1000 people):

Increased liver enzyme concentration (observed in a blood test) and pancreatitis, kidney stone or gallstone pain (renal or biliary colic), withdrawal symptoms, orthostatic hypotension (a type of hypotension that occurs when standing up, having been sitting or lying down)

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

Respiratory difficulty, muscle cramps, seizures, burning and itching, increased pain sensitivity, blurred vision, double vision, involuntary eye movement, a condition in which the intestine does not function correctly (ileus), abdominal pain, rash, swelling of the hands, ankles, or feet, general malaise, chills, syndrome of inappropriate antidiuretic hormone secretion (SIADH, syndrome of inappropriate antidiuretic hormone secretion) (symptoms: nausea, general 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, dizziness, hypoglycemia, nausea, diarrhea, vomiting, and abdominal pain), euphoria (strong 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. Severe skin reaction with blisters, generalized scaly skin, pus-filled patches, and fever. This could be a condition called generalized acute pustular exanthema (PEGA). Sleep apnea (pauses in breathing during sleep). Symptoms associated with pancreatitis and biliary tract system inflammation, p. intense pain in the upper abdomen that may radiate to the back, nausea, vomiting, or fever.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usewww.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and the bottle. The expiration date is the last day of the month indicated.

Do not refrigerate or freeze.

The bottle should be used within 4 weeks after the first opening.

Medicines should not be thrown into the drains or trash. Dispose of the containers and medicines you no longer need at the SIGRE point of the pharmacy or any other medication waste collection system. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Dropizol

• The active principle is: opium tincture

Each milliliter of oral solution contains 1 ml of opium tincture fromPapaver somniferum(L.), Succus siccus(pure opium), which is equivalent to 10 mg of morphine.

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

Each milliliter contains 20 drops.

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

Appearance of the product and contents of the container

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

Presentations: 1 × 10 ml, 2 x 10 ml, 3 × 10 ml, 4 x 10 ml, 5 x 10 ml and 10 × 10 ml.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Pharmanovia A/S

Ørestads Boulevard 108, 5

DK- 2300KøbenhavnS

Denmark

Email: [email protected]

Responsible for manufacturing

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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

This medicine is authorized in the member states of the European Economic Area with the following names:

Denmark:Dropizol

Iceland:Dropizol

Finland:Dropizol

Norway:Dropizol

Sweden:Dropizol

RU:Dropizol

Austria:Dropizol

Belgium:Dropizole

Czech Republic:Dropizol

Germany:Dropizol

Spain:Dropizol

France:Dropizal

Hungary:Dropizol

Ireland:Dropizol

Italy:Dropizole

Luxembourg:Dropizol

The Netherlands:Dropizol

Portugal:Dropizale

Romania:Dropizol

Slovak Republic:Dropizol

Last review date of this leaflet:June 2024.

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/