Simalvia

PACKAGE INSERT

Package insert: information for the patient

SimAlvia 60 mg/300 mg, soft capsules

Alverine citrate / Simethicone
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What SimAlvia soft capsules are and what they are used for
2. What you need to know before taking SimAlvia soft capsules
3. How to take SimAlvia soft capsules
4. Possible side effects
5. How to store SimAlvia soft capsules
6. Contents of the pack and other information

1. What SimAlvia soft capsules are and what they are used for

SimAlvia soft capsules contain two active substances:

• Alverine citrate, which belongs to a class of medicines called smooth muscle relaxants (musculotropic antispasmodics)
• Simethicone, which belongs to a class of medicines called anti-foaming agents (antiflatulents). This medicine reduces intestinal muscle contractions and flatulence (gas).

It is used to relieve pain associated with intestinal contractions (spasms) and bloating.
This medicine is intended for adults only.

2. What you need to know before taking SimAlvia soft capsules

Do not take SimAlvia soft capsules:

• if you are allergic to alverine citrate or simeticone, or to any of the other ingredients of this medicine (listed in section 6);
• if you have experienced adverse effects after taking this medicine;
• if you are allergic to peanuts or soy, because SimAlvia contains soy lecithin;
• if your doctor has told you that you have paralytic ileus;
• if you suffer from severe constipation;
• if you are pregnant;
• if you are breastfeeding.

Consult your doctor if you develop new symptoms, or if your symptoms worsen or do not improve after
2 weeks of treatment.
Other medicines and SimAlvia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines, including medicines without a prescription.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
The safety of alverine citrate during pregnancy and breastfeeding has not been established.
Therefore, it should be taken only if recommended by your doctor.
SimAlvia contains soy lecithin
If you are allergic to peanuts or soy, do not take this medicine.

3. How to take SimAlvia

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Dosing
The recommended dose is 1 capsule 2 or 3 times daily.
Method of administration
This medicine should be taken orally at the beginning of meals. Swallow the capsule with a glass of water.
If you take more SimAlvia than you should
Dizziness has been reported after taking a higher than recommended dose. Consult your doctor or pharmacist immediately.
If you forget to take SimAlvia
Do not take a double dose to make up for the missed capsule.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you experience any of the following side effects, stop treatment and contact a doctor immediately:

• signs of a severe allergic reaction, particularly swelling of the face, lips, mouth, tongue and/or throat, which may cause difficulty in breathing or swallowing, skin rash, itching, severe dizziness with increased heart rate and profuse sweating (severe allergic reaction considered very rare, i.e. affecting less than 1 in 10,000 people).
• signs indicating liver dysfunction. Symptoms may include yellowing of the skin or whites of the eyes, dark-coloured urine, pale stools, loss of appetite, unexplained and persistent nausea, unusual tiredness or vomiting (liver-related effect considered very rare, i.e. affecting less than 1 in 10,000 people).

The following additional side effects have been reported with unknown frequency (available data do not allow estimation of frequency):

• Skin rash;
• urticaria (pale or red skin with swellings that may itch, burn or sting);
• itching;
• dizziness;
• headache;
• nausea (feeling unwell);
• increased blood levels of liver enzymes (transaminases, alkaline phosphatase) and bilirubin (see section 2).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 SimAlvia soft capsules

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
Keep in the outer cardboard box to protect the medicine from light.
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.

6. Package contents and other information

What SimAlvia contains

• The active substances in one soft capsule are: alverine citrate (60 mg) and simethicone (300 mg).
• The other components of the soft capsule shell are: gelatin, glycerol, titanium dioxide; soy lecithin and fractionated coconut oil are used as external lubricants.

Description of the appearance of SimAlvia and pack contents
This medicine is presented as white, oval soft capsules.
Each pack contains 20, 30, 60 or 90 soft capsules in blisters.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratoires GALENIQUES VERNIN
20, rue Louis-Charles Vernin
77190 Dammarie-les-Lys
France

Manufacturer
Catalent France Beinheim SA
74, rue Principale,
67930 Beinheim
France
or
Laboratoires MAYOLY SPINDLER
6, Avenue de l’Europe – BP 51
78401 CHATOU CEDEX
France
or
Creapharm Industry
29, rue Léon Faucher
51100 Reims
France

This medicinal product is authorised in the European Economic Area countries under the following names:
Ireland: Spasmalvex
Italy: SimAlvia