Antispasmina colica

Package leaflet: Information for the patient

Antispasmina Colica 10 mg + 10 mg coated tablets, Forte 50 mg + 10 mg coated tablets

papaverine hydrochloride + belladonna
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What Antispasmina Colica is and what it is used for

Antispasmina Colica contains two active substances, papaverine hydrochloride and belladonna, and is used to promote relaxation of the muscles in the intestine and stomach (gastrointestinal tract).
Antispasmina Colica is used in the treatment of spasms and pain affecting the stomach and intestine.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before taking Antispasmina Colica

Do not take Antispasmina Colica

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other medicines belonging to the same class as Antispasmina Colica, particularly atropine, methyl homatropine, scopolamine, drotaverine, moxaverine;
• if you have a disease caused by high pressure inside the eye (glaucoma);
• if you have an enlarged gland called prostate (prostatic hypertrophy);
• if you have a narrowing of the lower part of the stomach (pyloric stenosis);
• if you have urinary tract diseases due to narrowing (stenosing urinary tract disorders);
• if you have obstructions in the stomach or intestines (paralytic ileus and obstructive gastrointestinal disorders);
• if you are an elderly or debilitated patient with reduced intestinal muscle tone;
• if you have inflammation of the colon (ulcerative colitis, toxic megacolon);
• if you have a severe muscle disease (myasthenia gravis);
• if you have disorders of the autonomic nervous system;
• if you have liver or kidney diseases;
• if you have excessive thyroid activity (hyperthyroidism);
• if you have heart vessel diseases (coronary arteries), heart rhythm disorders, high blood pressure (arterial hypertension), or if your heart does not provide adequate blood flow (congestive heart failure);
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding");
• if you are taking certain medicines that may alter the effect of Antispasmina Colica (see "Other medicines and Antispasmina Colica").

Antispasmina Colica is contraindicated in children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Antispasmina Colica.
If after a short period of treatment no appreciable improvement occurs, consult your doctor.
In elderly patients, Antispasmina Colica should be used only when strictly necessary and under direct medical supervision.
This medicine should not be taken concurrently with certain medicines that may alter the effect of Antispasmina Colica (see "Other medicines and Antispasmina Colica").
The appearance of adverse effects requires discontinuation of treatment.
Children
Antispasmina Colica is contraindicated in children under 12 years of age.
Other medicines and Antispasmina Colica
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use Antispasmina Colica if you are undergoing treatment with:

• antihistamines (used in the treatment of allergies),
• butyrophenones (used in the treatment of psychosis, mental disorders),
• phenothiazines (used to treat allergies, nausea and vomiting, or mental disorders),
• tricyclic antidepressants (used in the treatment of depression),
• amantadine (used in the treatment of Parkinson's disease),
• sulfonamides (used against bacterial infections),
• beta-blockers (used to regulate heart rhythm, chest pain (angina), and high blood pressure).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Antispasmina Colica must not be used during pregnancy and/or breastfeeding.
Driving and using machines
Antispasmina Colica impairs the ability to drive or operate machinery because it may cause drowsiness; you should bear this in mind when performing tasks requiring alertness (such as driving vehicles and operating machinery).
Antispasmina Colica contains:

• sucrose and lactose; if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
• castor oil, which may cause gastrointestinal disturbances and diarrhea.

3. How to take Antispasmina Colica

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults is:

• 2 to 6 tablets per day for Antispasmina Colica 10 mg + 10 mg
• 1 to 3 tablets per day for Antispasmina Colica Forte 50 mg + 10 mg.

Warning: do not exceed the recommended doses without medical advice.
The tablets should be swallowed before meals or as needed.
The tablets must not be chewed, but swallowed whole, as they need to reach the intestine intact in order to exert their effect.
Consult your doctor if symptoms recur frequently or if you have noticed any recent changes in their characteristics.
Warning: use only for short-term treatment.
In case of diarrhoea, the tablets may exceptionally be expelled undissolved; in such cases, it is advisable to take the tablets crushed, at least for a few days.
Use in children
Antispasmina Colica is contraindicated in children under 12 years of age.
If you take more Antispasmina Colica than you should
At high doses, Antispasmina Colica may cause:

• difficulty in urinating (urinary retention),
• changes in heart rhythm,
• breathing difficulties,
• agitation,
• mental confusion. In case of accidental ingestion/overdose of Antispasmina Colica, contact your doctor immediately or go to the nearest hospital.

If you forget to take Antispasmina Colica
Do not take a double dose to make up for the missed tablet.
If you stop treatment with Antispasmina Colica
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

• The following adverse reactions have been reported after treatment with normal doses of Antispasmina Colica:
• dry mouth,
• nausea,
• vomiting,
• presence in the esophagus of material regurgitated from the stomach (gastroesophageal reflux),
• localized pain behind the sternum,
• increased heart rate,
• increased intraocular pressure,
• difficulty in urination,
• constipation,
• dizziness,
• drowsiness,
• eye inflammation (conjunctivitis),
• allergic reactions, skin reactions, urticaria,
• yellow-brown discoloration of the skin (jaundice) and abnormal liver function laboratory tests.

At high doses, urinary retention, changes in heart rhythm, breathing difficulties, agitation, and mental confusion may occur.

Following the instructions provided in this leaflet reduces the risk of adverse reactions.
These adverse reactions are generally temporary. However, if they occur, it is advisable to consult your doctor or pharmacist.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. How to store Antispasmina Colica

This medicine does not require any special storage conditions.
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 packaging after "Expiry".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
It is important to always keep the medicine information available; therefore, retain both the packaging and the leaflet.

6. Package contents and other information

What Antispasmina Colica contains
Coated tablets 10 mg + 10 mg (Antispasmina Colica)

• The active substances are: papaverine hydrochloride and belladonna. Each coated tablet contains 10 mg of papaverine hydrochloride (equivalent to 9.016 mg of papaverine) and 10 mg of 1% hyoscyamine belladonna extract.
• The other components are: lactose, maize starch, povidone, magnesium stearate, precipitated silica, shellac, castor oil, cellulose acetophthalate, diethyl phthalate, magnesium carbonate, talc, vegetable charcoal, arabic gum, sucrose.

Coated tablets 50 mg + 10 mg (Antispasmina Colica Forte)

• The active substances are: papaverine hydrochloride and belladonna. Each coated tablet contains 50 mg of papaverine hydrochloride (equivalent to 45.08 mg of papaverine) and 10 mg of 1% hyoscyamine belladonna extract.
• The other components are: lactose, maize starch, povidone, magnesium stearate, precipitated silica, shellac, castor oil, cellulose acetophthalate, diethyl phthalate, magnesium carbonate, talc, vegetable charcoal, arabic gum, sucrose.

Description of the appearance of Antispasmina Colica and contents of the pack
Antispasmina Colica is presented as coated tablets for oral use.
It is available in packs of 30 tablets.
Marketing Authorization Holder and Manufacturer
RECORDATI Industria Chimica e Farmaceutica S.p.A. - via M. Civitali, 1 - 20148 Milan