DROPIZOLE 10 mg /Ml Oral Drops, Solution

Зміст інструкції

1. Dropizole 10 mg/ml oral drops, solution
   1. What is Dropizole and what is it used for
   2. What you need to know before you take Dropizole
   3. How to take Dropizole
   4. Possible side effects
   5. How to store Dropizole
   6. Contents of the pack and other information

Dropizole 10 mg/ml oral drops, solution

Morphine in opium tincture

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Dropizole and what is it used for

Dropizole is a herbal medicine that contains morphine.
Dropizole belongs to a group of medicines called antipropropulsive agents, and is used in adults for the
treatment of symptoms of severe diarrhea, Dropizole when the use of other treatments to
stop diarrhea have not achieved sufficient effect.
Dropizole works by inhibiting intestinal movements.

2. What you need to know before you take Dropizole

Do not take Dropizole:

• If you are allergic to opium or morphine or to any of the other ingredients of this medicine (listed in section 6).
• If you are addicted to opioids
• If you suffer from glaucoma (increased pressure in the eye)
• If you have a severe kidney or liver disease
• If you have symptoms of alcohol withdrawal (delirium tremens).
• If you have a severe head trauma
• If you are at risk of paralytic ileus (intestinal obstruction due to paralysis of the intestinal muscles)
• If you suffer from acute asthma, a chronic lung disease that makes it difficult to breathe (COPD)
• If you have breathing problems due to severe respiratory depression. Your doctor will have informed you if you suffer from any of these conditions. Symptoms may include shortness of breath, cough, or slower or weaker breathing than expected.
• If you have heart failure secondary to lung disease (cor pulmonale)
• If you are breastfeeding

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Dropizole:

• 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 suffer from narcotic or alcohol addiction
• If you have a disease of the gallbladder or gallstones
• If you have a head trauma or increased intracranial pressure
• If you have a reduced state of consciousness
• If you are taking a medicine for depression (moclobemide or other MAO inhibitors) or if you have stopped using this medicine in the last 2 weeks.
• If you have reduced adrenal function
• If you have an underactive thyroid, the dose may need to be adjusted.
• Low blood pressure with decreased blood volume
• Pancreatitis
• If you have prostatic hyperplasia (enlarged prostate) and/or conditions that predispose to urinary retention.
• If you have an infection or inflammation of the intestine, as inhibition of peristalsis may increase the risk of absorption of toxins, the development of a dilated colon, and perforation of the intestine.
• If you suffer from epilepsy
• If you are taking other medicines against diarrhea
• If you experience convulsions
• If you have bleeding in the stomach and/or intestine
• If you are taking medicines for high blood pressure

If you experience difficulty urinating, you should contact a healthcare professional.
Due to the risk of paralytic ileus, whose symptoms are nausea and vomiting, Dropizole is not
recommended before surgery or within 24 hours after an operation.
Risk of dependence and tolerance when using the product.

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

Other medicines and Dropizole
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
It is particularly important that you inform your doctor or pharmacist if you are taking:

• Medicines that enhance the reduction of the state of consciousness and difficulty breathing as seen with Dropizole, such as
• Alcohol
• Sleeping pills (e.g. zolpidem) and general anesthetics (e.g. barbiturates)
• Medicines to treat depression (tricyclic antidepressants) or Parkinson's disease (MAO inhibitors e.g. safinamide)
• Antipsychotic medicines with a sedative effect (e.g. phenothiazines)
• Medicines to treat epilepsy (gabapentin)
• Medicines to relieve nausea and vomiting (e.g. bromopride, meclizine, metoclopramide)
• Medicines to relieve allergies (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 mode of action similar to morphine and therefore may increase withdrawal symptoms and reduce the therapeutic effect (buprenorphine, nalbuphine, nalmefene, naltrexone, pentazocine)
• Medicines to treat alcohol abuse (disulfiram) or medicines to treat some types of infections (metronidazole), as they can cause unpleasant side effects such as hot flashes, rapid breathing and increased heart rate
• Medicines to treat tuberculosis (r ifampicin) decrease the effect of morphine
• Some drugs used to treat blood clots (e.g. clopidogrel, prasugrel, ticagrelor) may have a delayed and reduced effect if taken in combination with opioids. Amphetamine and analogues can reduce the sedative effect of opioids
• Loxapine and periciazine can increase the sedative effect of opioids
• The concomitant use of flibanserin and opioids may increase the risk of CNS depression
• Opioids can increase plasma concentrations of desmopressin and sertraline
• Zidovudine (medicine to treat or prevent HIV infections).
• Medicines to treat depression (fluoxetine) can reduce the duration of action of morphine

The concomitant use of Dropizole and sedatives such as benzodiazepines and related drugs, increases the
risk of dizziness, breathing difficulties (respiratory depression), coma and may be
potentially fatal. Because of this, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes Dropizole together with sedatives, the dose and duration of concomitant treatment
must be limited by your doctor.
Tell your doctor about all the sedatives you are taking and carefully follow the recommendation
on the dose made by your doctor. It may be helpful to inform friends or family to be aware of the
appearance of the signs and symptoms indicated above. Contact your doctor if you experience such symptoms.
The concomitant administration of morphine may increase the effects of drugs that
decrease blood pressure or other drugs with a blood pressure lowering effect.

Dropizole with food, drinks and alcohol
Dropizole can be taken with food and drinks. Dropizole contains alcohol, therefore extreme caution must be exercised when consuming alcohol.
See “Dropizole contains ethanol” below.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy:
Do not take Dropizole during pregnancy unless instructed by your doctor. Dropizole should not
be taken near the date of delivery due to the risk of withdrawal symptoms in the
newborn.
Breastfeeding:
Dropizole should not be used during breastfeeding.
Fertility
It is not known whether morphine can harm fertility. Fertile men and women should use
an effective method of contraception when using Dropizole.

Driving and using machinery
Dropizole contains morphine and ethanol and can cause drowsiness and significantly affect the ability to drive or operate machinery.
Do not drive or use machinery until you know how these substances affect you.

Dropizole contains ethanol
This medicine contains 33 vol % ethanol (alcohol), which is 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 consideration in pregnant or breastfeeding women, children and
high-risk groups such as patients with liver disease or epilepsy.

3. How to take Dropizole

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
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.
Elderly: the dosage must be reduced.
Hepatic insufficiency: Dropizole should not be used or the dosage should be reduced. See
paragraph 2 "Do not take" and paragraph 2 "Warnings and precautions".
Renal insufficiency: Dropizole should not be used or the dosage should be reduced.
See paragraph 2 "Do not take" and paragraph 2 "Warnings and precautions".
There are approximately 20 drops in 1 ml.
Method of administration
Oral use.
Dropizole can be used undiluted or mixed in a glass of water. After being
mixed in water, it must be used immediately. If Dropizole is used undiluted, the
correct dosage can be administered with a spoon.

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

If you take more Dropizole than you should
If you take too much Dropizole you may experience small pupils, slow heart rate, low blood
pressure, pulmonary edema, difficulty breathing and decreased levels of consciousness which may
lead to coma. Call your doctor if you have taken more Dropizole than prescribed by your doctor or

If you forget to take Dropizole
You should take the missed dose as soon as you remember, unless it is almost time for the
next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Dropizole
Continue to take the medicine for the time that has been indicated to you by your doctor.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Common(may affect up to 1 in 10 people)
Difficulty in urination

Uncommon(may affect up to 1 in 100):
Shortness of breath, fatigue, anxiety, bluish lips and fingertips, headache, confused state,
seizures, swelling of the legs and feet (respiratory depression).
Cardiac arrhythmia (fast or slow heartbeat).

Other side effects
Very common(may affect more than 1 in 10 people):
Drowsiness, constipation and dry mouth

Common(may affect up to 1 in 10 people):
Dizziness, headache, pupil constriction, nausea and vomiting, loss of appetite, indigestion
or discomfort, altered taste and smell, urticaria, sweating, bronchospasm, decreased
cough, asthenia

Uncommon(may affect up to 1 in 100):
Hot flushes, itching, spasms in the lower urinary tract, abnormal liver tests

Rare(may affect up to 1 in 1,000):
Increased pancreatic enzymes (detected by blood tests) and inflammation of the pancreas,
pain due to kidney stones (renal colic) or gallbladder (biliary colic), withdrawal symptoms,
orthostatic hypotension (a form of low blood pressure that occurs when getting up from a seated or
lying position)

Very rare(may affect up to 1 in 10,000):
Difficulty breathing, muscle cramps, seizures, burning and stinging pain, increased
sensitivity to pain, blurred vision, double vision, involuntary eye movements,
condition in which the intestine does not function properly (ileus), abdominal pain, rash,
swelling of the hands, ankles or feet, feeling unwell, chills, inappropriate
secretion of antidiuretic hormone (SIADH) syndrome (symptoms: nausea, malaise, headache, fatigue,
and in severe cases can progress to seizures and coma), absence of menstruation.

Not known(the 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, dependence, dysphoric mood (sad, without
energy), restlessness, decreased libido or sexual potency, hallucinations, vertigo and
fever.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or
nurse. You can also report side effects directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Dropizole

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and the bottle after
exp. The expiry date refers to the last day of that month.
This medicine does not require any particular precautions for storage.
After first opening, the bottle can be used for 4 weeks.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dropizole contains
The active ingredient is: opium tincture
1 ml of oral liquid contains 1 ml of tincture of Papaver somniferum L., dried juice
(crude opium) corresponding to 10 mg of morphine.
1 drop contains 50 mg of opium tincture equivalent to 0.5 mg (10 mg/ml) of anhydrous morphine.
1 ml contains 20 drops.
Extraction solvent: ethanol 33% (V/V)
Excipients

• Ethanol 96% V/V
• Purified water

Description of Dropizole and contents of the pack
Dropizole is a dark liquid, of reddish-brown color. It is available in brown glass bottles
with dropper and child-resistant closure.
Pack sizes 1 x 10 ml, 2 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

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Atnahs Pharma Nordics A/S
Ørestads Boulevard 108, 5
DK-2300 Copenhagen S
Denmark
e-mail: [email protected]

Manufacturer
Lomapharm GmbH
Langes Feld 5
D-31860 Emmerthal
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

This medicinal product is authorised in the Member States of the EEA under the following
names:
Austria Dropizol
Belgium Dropizole
Czech Republic Dropizol
Germany Dropizol
Denmark Dropizol
Spain Dropizol
Finland Dropizol
France Dropizal
Hungary Dropizol
Ireland Dropizol
Iceland Dropizol
Italy Dropizole
Luxembourg Dropizol
Dropizol
Netherlands Dropizol
Norway Dropizol
Portugal Dropizale
Romania Dropizol
Sweden Dropizol
Slovakia Dropizol
United Kingdom Dropizol