Spasmex

Patient Information Leaflet

Spasmex 80 mg + 80 mg tablets, 150 mg + 150 mg suppositories

Floroglucinol and 1,3,5-Trimethoxybenzene
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 side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Spasmex is and what it is used for

Spasmex contains the active ingredients floroglucinol and 1,3,5-trimethoxybenzene.
Spasmex is a medicine indicated in adults for the symptomatic treatment of pain related to
functional disorders of the gastrointestinal tract and bile ducts.
Treatment of acute painful spasmodic conditions of the urinary tract: renal colic.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Spasmex

Do not take Spasmex

• if you are allergic to floroglucinol, 1,3,5-trimethoxybenzene, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Spasmex.
Currently, no specific warnings or precautions have been reported for Spasmex.
Children and adolescents
Use in children and adolescents is not recommended, as safety and efficacy have not been established.
Patients with renal/hepatic impairment
Data regarding the use of Spasmex are not available.
Other medicines and Spasmex
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking a class of medicines called strong analgesics, medicines used in pain therapy such as morphine and its derivatives.
Indeed, these medicines may cause sudden painful contractions.
Spasmex tablets contain lactose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Spasmex suppositories contain sodium sulfite
Rarely, this may cause severe hypersensitivity reactions and bronchospasm (narrowing of the bronchi causing severe breathing difficulties due to reduced airflow).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Take this medicine only if strictly necessary and under direct medical supervision.
Breastfeeding
No data are available regarding the use of Spasmex during breastfeeding. Therefore, avoid using Spasmex while breastfeeding.
Driving and using machines
Spasmex does not affect the ability to drive vehicles or operate machinery.

3. How to take Spasmex

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Tablets
The recommended dose is 6 tablets per day.
Suppositories
The recommended dose is 3 suppositories per day.
Patients with renal/hepatic impairment
Data regarding the use of Spasmex are not available.
Use in children and adolescents
Use in children and adolescents is not recommended, as safety and efficacy have not been established.
How to take
Tablets
The tablets should be taken orally.
Suppositories
The suppositories should be administered rectally.
If you take more Spasmex than you should
Cases of overdose have not been reported.
If you forget to take Spasmex
Do not take a double dose to make up for the forgotten dose.
If you stop taking Spasmex
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects have been reported after administration of Spasmex, according to frequency:

Very rare (may affect less than 1 in 10,000 people):

• Skin rash
• Skin redness accompanied by itching (urticaria)
• Swelling of the legs, arms, face or tongue (angioedema)
• Decreased blood pressure (hypotension)

Not known (frequency cannot be estimated from the available data):

• A widespread, red, scaly skin eruption, with subcutaneous nodules and blisters accompanied by fever at the beginning of treatment (generalized pustular exanthema, acute)

A severe allergic reaction (anaphylactic shock) has been reported with injectable Spasmex during post-marketing experience.
Stop using this medicine if you develop any of these symptoms and contact your doctor immediately.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor. You may also report side effects directly via the national reporting system at 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 Spasmex

Keep this medicine out of the sight and reach of children.
Suppositories: this medicine requires no special storage conditions.
Tablets: store below 25°C.
Do not use Spasmex tablets if you notice spots appearing on the tablet or if the colour is not uniform.
Do not use this medicine after the expiry date stated on the packaging after EXP. 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 no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Spasmex contains
Tablets

• The active substances are: floroglucinum dihydrate 102.850 mg (equivalent to 80 mg anhydrous floroglucinum) and 1,3,5-trimethoxybenzene 80 mg
• The other components are: lactose, sucrose (see section 2 “Spasmex tablets contain lactose and sucrose”), magnesium stearate, talc.

Suppositories

• The active substances are: floroglucinum dihydrate 193 mg (equivalent to 150 mg anhydrous floroglucinum) and 1,3,5-trimethoxybenzene 150 mg
• The other components are: sodium sulfite (see section 2 “Spasmex suppositories contain sodium sulfite”), solid semisynthetic glycerides.

Description of Spasmex and contents of the pack
Tablets
Spasmex tablets are packed in blisters, in a carton containing 20 tablets.
Suppositories
Spasmex suppositories are packed in blisters, in a carton containing 6 suppositories.

Marketing Authorization Holder
SCHARPER S.p.A. - Viale Ortles, 12 – 20139 Milan
Manufacturer
Tablets
Doppel Farmaceutici S.r.l. – Via Volturno, 48 – 20089 Quinto de' Stampi Rozzano (MI)
Suppositories
Doppel Farmaceutici S.r.l. – Via Martire delle Foibe, 1 – 29016 Cortemaggiore (PC)

Patient information leaflet

Spasmex 40 mg/4 ml solution for injection

Floroglucinol
Please read this leaflet carefully before using 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may 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:

7. What Spasmex is and what it is used for
8. What you need to know before taking Spasmex
9. How to take Spasmex
10. Possible side effects
11. How to store Spasmex
12. Package contents and other information

1. What Spasmex is and what it is used for

Spasmex contains the active substance floroglucinum.
Spasmex is a medicine indicated in adults for the symptomatic treatment of pain
associated with functional disorders of the gastrointestinal tract and bile ducts.
Treatment of acute painful spasmodic conditions of the urinary tract: renal colic.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Spasmex

Do not take Spasmex

• if you are allergic to floctafenine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Spasmex.
At present, no specific warnings or precautions have been reported for Spasmex.
Patients with renal/hepatic impairment
Data regarding the use of Spasmex in these patients are not available.
Children and adolescents
Use in children and adolescents is not recommended, as safety and efficacy have not been established.
Other medicines and Spasmex
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking a class of medicines called strong analgesics, used in pain therapy, such as morphine and its derivatives. Indeed, these medicines may cause sudden painful contractions.
Moreover, do not mix the injectable solution of floctafenine with noramidopyrine (a medicine for pain and fever) in the same syringe, as floctafenine is not compatible with noramidopyrine (risk of phlebothrombosis, i.e. formation of blood clots in the vein).
Spasmex contains sodium metabisulfite
Rarely, it may cause severe allergic reactions and bronchospasm (narrowing of the airways causing severe breathing difficulties due to reduced airflow).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Take this medicine only if strictly necessary and under direct medical supervision.
Breastfeeding
There are no data available on the use of Spasmex during breastfeeding. Therefore, avoid using Spasmex while breastfeeding.
Driving and using machines
Spasmex does not affect the ability to drive or operate machinery.
Spasmex contains sodium sulfite and sodium metabisulfite:
Rarely, these may cause severe hypersensitivity reactions and bronchospasm.
Spasmex contains sodium:
This medicine contains 12.1 mg of sodium (the main component of table salt) per vial. This corresponds to 0.61% of the maximum daily recommended dietary intake for an adult.

3. How to take Spasmex

Use this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Adults:
The recommended dose is:

• Initial treatment: 1 vial administered intravenously, which may be repeated after 1/2 hour if necessary
• Maintenance treatment: 1 vial 1 or 2 times daily, administered intravenously or intramuscularly.

Use in children and adolescents
Use in children and adolescents is not recommended, as safety and efficacy have not been established.
How to use
Spasmex will be administered to you intravenously or intramuscularly.
In particular, intravenous administration of Spasmex requires intervention by specialized personnel.
Prolonged exposure of Spasmex vials to cold environments may cause crystal formation, which completely disappears by warming and gently shaking the vials for two minutes in warm water.
This phenomenon, as well as a slight yellowish discoloration of the vial, does not impair either the medicinal activity or the safety of the product.
If you take more Spasmex than you should
Overdose syndromes are not known.
If you forget to use Spasmex
Do not use a double dose to make up for the forgotten dose.
If you stop treatment with Spasmex
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects have been reported after administration of Spasmex, according to frequency:

Very rare (may affect less than 1 in 10,000 people)

• Skin rash
• Skin redness accompanied by itching (urticaria)
• Swelling of legs, arms, face or tongue (angioedema)
• Decreased blood pressure (hypotension)
• Severe allergic reaction (anaphylactic shock)

Not known (frequency cannot be estimated from the available data):

• Widespread, red, scaly skin eruption, with formation of subcutaneous nodules and blisters, accompanied by fever at the beginning of treatment (generalized acute exanthematous pustulosis)

Stop using this medicine if you develop any of these symptoms and contact your doctor immediately.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You may also report side effects directly through the national reporting system at 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 Spasmex

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after
EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents

What Spasmex contains

• The active substance is: floroglucinum dihydrate 51.43 mg (equivalent to anhydrous floroglucinum 40 mg)
• The other components are: sodium chloride, sodium metabisulphite (see section “Spasmex contains sodium metabisulphite”), sodium sulphite, water for injections.

Pharmaceutical form and pack sizes
Spasmex is a solution for injection. It is available in packs of 10 glass vials of 40 mg/4 ml.
Marketing Authorisation Holder
SCHARPER S.p.A. - Viale Ortles, 12 – 20139 Milan, Italy.
Manufacturer
Doppel Farmaceutici s.r.l. - Via Volturno, 48 – Quinto Dè Stampi – Rozzano (MI).