Kilspax

Package leaflet: Information for the patient

KILSPAX 80 mg orodispersible tablets

floroglucinol dihydrate
Equivalent medicine
Please read all of 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 told you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, contact 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 your symptoms worsen.

Contents of this leaflet

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

1. What KILSPAX is and what it is used for

KILSPAX belongs to a group of medicines known as antispasmodics.
This medicine is indicated for the treatment of pain caused by spasms (cramps) in the intestine, bile ducts, bladder, and uterus.
Consult your doctor if you do not notice any improvement or if your symptoms worsen.

2. What you need to know before taking KILSPAX

Do not take KILSPAX:

• If you are allergic to dihydrofluroglucinol or any of the other ingredients of this medicine (listed in section 6).
• If you have phenylketonuria (an inherited disease present at birth), due to the presence of aspartame. If in doubt, consult your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before taking KILSPAX.
Other medicines and KILSPAX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Avoid combining KILSPAX with strong analgesics (medicines used to relieve pain) such as
morphine or its derivatives, due to their spasmogenic effect.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Take KILSPAX only if advised by your doctor.
Do not take this medicine if you are breastfeeding.
Driving and using machines
KILSPAX has no effect or has a negligible effect on the ability to drive vehicles or operate machinery.
KILSPAX contains lactose monohydrate and aspartame (E951)
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this
medicine.
Each KILSPAX tablet contains 2 mg of aspartame. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it (see section Do not take KILSPAX).

3. How to take KILSPAX

Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you. The active substance is a symptomatic treatment. If symptoms persist, consult your doctor.

The recommended dose is:
Adults: 2 tablets to be taken at the time of the attack, repeated if significant spasms occur, with a minimum interval of 2 hours between each dose, without exceeding 6 tablets in 24 hours.
Use in children over 2 years of age: 1 tablet to be taken at the time of the attack, repeated if significant spasms occur, with a minimum interval of 2 hours from the previous dose, without exceeding 2 tablets in 24 hours.

Method of administration
Adults: Dissolve the tablets under the tongue for rapid effect or in a glass of water.
Children: Dissolve the tablets in a glass of water. The reconstituted solution must be taken immediately.

If you take more KILSPAX than you should
If you accidentally take too many tablets or if you think a child has ingested some, contact the nearest hospital emergency department or see a doctor immediately, bringing the packaging of the ingested medicine with you.

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 everybody will experience them.
Allergic skin and mucous membrane reactions: skin rash, rare cases of urticaria, pruritus, Quincke's edema, very rare cases of angioedema (a severe allergic reaction causing swelling of the face or throat), low blood pressure, and anaphylactic shock (a severe allergic reaction causing breathing difficulties, dizziness, a severe drop in blood pressure, and loss of consciousness).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website 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 KILSPAX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the blister or container
after the word EXP. The expiry date refers to the last day of that month.
Store below 30 °C.
Blister: store in the original packaging (blister) to protect the medicine from moisture.
Bottles: keep the bottle tightly closed to protect the medicine from moisture.
The contents of the bottle must be used within 1 month of opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What KILSPAX contains

• The active substance is floroglucinol dihydrate.
• Other components: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone, magnesium stearate, aspartame (E951).

Description of the appearance of KILSPAX and contents of the package
Orodispersible uncoated tablets, round, white to off-white, smooth on both sides.
10, 20 or 30 tablets in blisters (PVC/PVDC/aluminum).
20 tablets in a container (HDPE).
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
VELIT BIOPHARMA S.r.l.
Piazza Cavour, 3
20121 – Milan, Italy
Manufacturer
PharmSol Europe Ltd.
KW20A Korradino Industrial Park
Paola PLA3000
Malta
This medicinal product is authorized in EEA Member States under the following brand names: