SPASMEX 150 mg/150 mg Суппозиторий

Содержание инструкции

1. Spasmex 80 mg + 80 mg tablets, 150 mg+ 150 mg suppositories
   1. What Spasmex is and what it is used for
   2. What you need to know before you take Spasmex
   3. How to take Spasmex
   4. Possible side effects
   5. How to store Spasmex
   6. Contents of the pack and other information
2. Spasmex 40 mg/4 ml injectable solution
   1. What is Spasmex and what is it used for
   2. What you need to know before you take Spasmex
   3. How to take Spasmex
   4. Possible side effects
   5. How to store Spasmex
   6. Package Contents

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

Floroglucinol and 1,3,5 Trimethoxybenzene

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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 digestive tract and biliary ducts.
Treatment of acute spasmodic painful conditions of the urinary tract: renal colic.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before you take 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 particular 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
No data are available regarding the use of Spasmex

Other medicines and Spasmex
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor if you are taking a class of medicines called strong analgesics,
medicines used in pain therapy such as morphine and its derivatives.
In fact, these medicines can cause the appearance of painful and sudden contractions.

Spasmex tablets contains lactose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking
this medicine.

Spasmex suppositories contains sodium sulfite
Rarely it may cause severe hypersensitivity reactions and bronchospasm (narrowing of the bronchi
which causes severe breathing difficulties due to reduced air passage).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Take this medicine only if really necessary and under direct medical supervision.

Breastfeeding
No data are known regarding the use of Spasmex during breastfeeding. Therefore, avoid the use of
Spasmex during breastfeeding.

Driving and using machines.
Spasmex does not alter the ability to drive vehicles and use machines.

3. How to take Spasmex

Take this medicine following exactly the instructions of 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 insufficiency
No data are available regarding the use of Spasmex

Use in children and adolescents
Use in children and adolescents is not recommended, as safety and efficacy have not been
established.

How

Tablets
The tablets must be taken orally.

Suppositories
The suppositories must be taken rectally.

If you take more Spasmex than you should
No cases of overdose have been reported.

If you forget to take Spasmex
Do not take a double dose to make up for a missed 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 everybody gets them.
The following side effects have been reported with the administration of Spasmex, based on
their 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)

Not known (frequency cannot be estimated based on available data):

• A widespread, red and scaly skin rash, with the formation of bumps under the skin and blisters accompanied by fever at the beginning of treatment (acute generalized pustulosis)

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor. You can 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 sight and reach of children.
Suppositories: this medicine does not require any special storage conditions.
Tablets: store at a temperature not exceeding 25°C.
Do not use Spasmex tablets if you notice the appearance of spots on the tablet or if the colour is not
uniform.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater 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 Spasmex contains

Tablets

• the active ingredients are: floroglucinol dihydrate 102.850 mg (equivalent to anhydrous floroglucinol 80 mg) and 1,3,5 trimethoxybenzene 80 mg
• the other ingredients are: lactose, sucrose(see section 2 “Spasmex tablets contains lactose and sucrose”), magnesium stearate, talc.

Suppositories

• the active ingredients are: floroglucinol dihydrate 193 mg (equivalent to anhydrous floroglucinol 150 mg) and 1,3,5 trimethoxybenzene 150 mg
• the other ingredients are: sodium sulfite(see section 2 “Spasmex suppositories contains sodium sulfite”), solid semi-synthetic glycerides.

Description of the appearance of Spasmex and contents of the pack

Tablets
Spasmex tablets are packaged in blisters in a carton containing 20 tablets.

Suppositories
Spasmex suppositories are packaged in blisters in a carton containing 6 suppositories.

Marketing Authorisation Holder
SCHARPER S.p.A. - Viale Ortles, 12 – 20139 Milano

Manufacturer

Tablets
Doppel Farmaceutici S.r.l. – Via Volturno, 48 – 20089 Quinto Dè Stampi Rozzano (MI)

Suppositories
Doppel Farmaceutici S.r.l. – Via Martire delle Foibe, 1 – 29016 Cortemaggiore (PC)

Spasmex 40 mg/4 ml injectable solution

Floroglucinol
Read this leaflet carefully before you start to use 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use Spasmex
• 9. How to use Spasmex
• 10. Possible side effects
• 11. How to store Spasmex
• 12. Contents of the pack and other information

1. What is Spasmex and what is it used for

Spasmex contains the active ingredient floroglucinol.
Spasmex is a medicine indicated in adults for the symptomatic treatment of pain
related to functional disorders of the digestive tract and bile ducts.
Treatment of acute spasmodic painful conditions of the urinary tract: renal colic.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before you take Spasmex

Do not take Spasmex

• if you are allergic to floroglucinol 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 particular warnings or precautions have been reported for Spasmex.

Patients with renal/hepatic insufficiency.
No data are available regarding the use of Spasmex.

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, tell your doctor if you are taking a class of medicines called strong analgesics,
medicines used in pain therapy such as morphine and its
derivatives. In fact, these medicines can cause the onset of painful and
sudden contractions.
In addition, do not mix the injectable solution of floroglucinol with
noramidopyrine (a medicine for pain and fever) in the same syringe, as fluoroglucinol is not
compatible with noramidopyrine (risk of phlebothrombosis, i.e. the formation of thrombi
in the vein).

Spasmex contains sodium metabisulfite
Rarely it may cause severe allergic reactions and bronchospasm (narrowing of the bronchi
which causes severe breathing difficulties due to reduced air passage).

Pregnancy and Breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Take this medicine only if really necessary and under direct medical supervision.

Breastfeeding
No data are available regarding the use of Spasmex during breastfeeding. Therefore, avoid
using Spasmex during breastfeeding.

Driving and using machines.
Spasmex does not impair the ability to drive vehicles and operate machinery.

Spasmex contains sodium sulfite and sodium metabisulfite:
Rarely they can 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 is equivalent to 0.61% of the maximum recommended daily intake with the
diet of an adult.

3. How to take Spasmex

Use this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.

Adults:
The recommended dose is:

• attack therapy: 1 vial to be administered intravenously, possibly to be repeated after 1/2 hour
• maintenance therapy: 1 vial 1 or 2 times a day to be 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
Spasmex will be administered to you intravenously or intramuscularly.
In particular, Spasmex when administered intravenously requires the intervention of specialized
personnel.
Prolonged exposure of Spasmex vials to cold environments may cause the
formation of crystals that disappear completely by warming and shaking the vials for
two minutes in warm water.
This phenomenon, as well as a slight yellowing of the vial, does not affect either the activity
of the medicine or its harmlessness.

If you take more Spasmex than you should
No overdose syndromes are known.

If you forget to use Spasmex
Do not use a double dose to make up for a missed 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 everybody gets them.
Following the administration of Spasmex, the following side effects have been reported
according to their frequency:

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

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

Not known(the frequency cannot be estimated on the basis of the available data):

• A widespread, red and scaly skin rash, with the formation of bumps under the skin and blisters accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis)

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor. You can 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 sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the packaging after
EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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

What Spasmex contains

• the active ingredient is: floroglucinol dihydrate 51.43 mg (equivalent to anhydrous floroglucinol 40 mg)
• other ingredients: sodium chloride, sodium metabisulfite(see section “Spasmex contains sodium metabisulfite”), sodium sulfite, water for injections.

Pharmaceutical form and pack
Spasmex is presented as an injectable solution. It is available in packs of 10 glass vials containing
40 mg/4 ml.

Marketing Authorisation Holder
SCHARPER S.p.A. - Viale Ortles, 12 – 20139 Milano.

Manufacturer
Doppel Farmaceutici s.r.l. - Via Volturno, 48 – Quinto Dè Stampi – Rozzano (MI).