Ticalma

TEST TEXT ON THE PRIMARY PACKAGING
TICALMA
400 mg
Herbal Tea 20 tea bags
VALERIANA Root
Before use, carefully read all information on the packaging
This medicine is available without a prescription.
However, it should be used carefully to achieve the best results.
Keep this packaging, as you may need to read it again. For further
information or advice, please consult your pharmacist.
If your symptoms worsen or do not improve after a short period of treatment, you must
contact your doctor.
WHAT TICALMA IS AND WHAT IT IS USED FOR
Pharmacotherapeutic category
TICALMA is a mild sedative of the central nervous system.
Therapeutic indications
TICALMA is used as a mild sedative, also to promote night-time rest.
BEFORE USING TICALMA
Do not use TICALMA if you have:
Hypersensitivity to the active substance or to any of the excipients.
Special warnings and precautions for use: The use of TICALMA is not recommended in children
under 12 years of age.
Interaction with other medicines, food and other forms of interaction
Valerian may enhance the central nervous system depressant effects caused by other
substances, such as barbiturates and chlorpromazine. Concomitant use of TICALMA with psychotropic drugs,
barbiturates or major sedatives requires medical diagnosis and supervision.
Ask your doctor or pharmacist for advice if you are taking other medicines, including those
available without a prescription.
The effect of TICALMA may be enhanced by concomitant alcohol consumption; alcohol intake
should therefore be avoided.
Pregnancy and breastfeeding
Use during pregnancy and breastfeeding is not recommended. If you are pregnant or breastfeeding, if you think you may be pregnant or are planning a pregnancy, consult your
doctor or pharmacist before taking TICALMA.
Effects on ability to drive and use machinery
Taking valerian-based preparations may reduce the ability to drive vehicles and operate
machinery.
HOW TO USE TICALMA
Dosage and method
FOR ORAL USE.
Adults: 1–2 tea bags to be taken 3 times daily after main meals and in the evening before bedtime.
Steep 1–2 tea bags for several minutes in an amount of water equivalent to one cup. Never boil. The tea may be consumed cold or hot, optionally sweetened with sugar and, if desired, with orange or lemon peel.
Do not exceed the recommended doses without medical advice.
Caution: use only for short periods of treatment. If symptoms worsen after 2 weeks of continuous treatment, consult your doctor.
Use in children
Do not use in children under 12 years of age.
If you take an excessive dose of TICALMA
Occasionally, if an excessive dose of TICALMA is taken, mild symptoms (fatigue, abdominal cramps, slight dizziness, chest tightness, hand tremors and mydriasis) may occur, which disappear within 24 hours.
In case of significant overdose, central nervous system depression is likely. In such cases, contact your doctor immediately or go to the nearest hospital.
What to do if you forget to take TICALMA
None. Do not take an extra dose beyond the recommended usage instructions.
Consult your doctor or pharmacist for any doubts regarding the use of this medicine.
POSSIBLE ADVERSE EFFECTS
After ingestion of valerian-based preparations, gastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur. Frequency is unknown.
Like all medicines, Ticalma can cause adverse effects.
Following the instructions in the package leaflet reduces the risk of adverse effects.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse effects directly
via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili”. By reporting adverse effects, you can help
provide more information on the safety of this medicine.
HOW TO STORE TICALMA
Do not use this medicine after the expiry date stated on the packaging.
This medicine does not require any special storage conditions.
Keep medicine out of sight and reach of children.
OTHER INFORMATION
Composition
One 1.2 g tea bag contains:
Active substance: Valeriana root 400 mg.
Excipients: Chamomile flowers, savory leaves, green anise seeds, peppermint leaves, lemon balm tops.
Pharmaceutical form and contents
“400 mg herbal tea” (pack of 20 tea bags)
Marketing Authorization Holder
KELEMATA S.r.l. Corso Re Umberto, 20 - 10128 Turin A.I.C. 008290088
Manufacturer and final controller
Kelemata S.r.l., Martellago (VE) plant, via Castellana, 120
OVER-THE-COUNTER MEDICINE NOT SUBJECT TO MEDICAL PRESCRIPTION
The expiry date stated refers to the product in intact packaging,
correctly stored.
Expiry date
Batch number

PACKAGE LEAFLET

TICALMA “100 mg FILM-COATED TABLETS”

Valerian dry extract
Please read this leaflet carefully as it contains important information for you.
This medicine is available without a doctor's prescription. However, you should use it carefully to achieve the best results.
Keep this leaflet, as you may need to read it again.
If you need further information or advice, consult your pharmacist.
If your symptoms worsen or do not improve after a short period of treatment, you should contact your doctor.
In this leaflet:

1. What TICALMA is and what it is used for
2. Before you take TICALMA
3. How to take TICALMA
4. Possible side effects
5. How to store TICALMA
6. Further information

1. WHAT TICALMA IS AND WHAT IT IS USED FOR

Pharmacotherapeutic category
TICALMA is a mild sedative of the central nervous system.
Therapeutic indications
TICALMA is used as a mild sedative, including to promote night-time rest.

2. BEFORE USING TICALMA

Do not use TICALMA if:
Hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions for use
The use of TICALMA is not recommended in children under 12 years of age due to
lack of data on safety and efficacy.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this
medicinal product.

Interaction with other medicinal products, food and other forms of interaction
Valerian may enhance the central nervous system depressant effects caused by other
substances, such as barbiturates and chlorpromazine. Concomitant use of TICALMA with psychotropic drugs,
barbiturates or major sedatives requires medical diagnosis and supervision.
Ask your doctor or pharmacist for advice if you are taking other medicinal products, including those
obtained without a prescription.
The effect of TICALMA may be enhanced by concomitant consumption of alcohol; alcohol consumption should therefore be avoided.

Pregnancy and breastfeeding
"Ask your doctor or pharmacist for advice before taking any medicinal product."
Use during pregnancy and breastfeeding is not recommended. If you are pregnant or breastfeeding, if you think you may be pregnant or are planning a pregnancy, consult your
doctor or pharmacist before taking TICALMA.

Effects on ability to drive and use machines
Taking valerian-containing preparations may impair the ability to drive vehicles and operate
machinery.

3. HOW TO USE TICALMA

Adults: 1-2 coated oral tablets, to be taken 3 times daily after main meals and in the evening before bedtime.
Do not chew the tablets. Swallow the tablet whole, with a glass of water.
Do not exceed the recommended doses without medical advice.
Warning: Use only for short-term treatment. If symptoms worsen after 2 weeks of continuous treatment, consult your doctor.

Use in children
Do not use in children under 12 years of age due to lack of safety and efficacy data.

If you take an excessive dose of TICALMA
Occasionally, if an excessive dose of TICALMA is taken, mild symptoms may occur (fatigue, abdominal cramps, mild dizziness, chest tightness, hand tremors, and mydriasis), which disappear within 24 hours.
In case of significant overdose, central nervous system depression may occur. In such cases, contact your doctor immediately or go to the nearest hospital.

If you forget to take TICALMA
No action required. Do not take a double dose to make up for the missed dose.
Consult your doctor or pharmacist if you have any doubts about the use of this medicine.

4. POSSIBLE ADVERSE REACTIONS

"Like all medicines, TICALMA can cause adverse reactions, although not everyone experiences them."
Gastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur after ingestion of valerian-containing preparations. The frequency is unknown.
"Following the instructions provided in this leaflet reduces the risk of adverse reactions."
Reporting of adverse reactions
If any adverse reaction occurs, including those not listed in this leaflet, consult your doctor or pharmacist. Adverse reactions can also be reported directly via the national reporting system at the website "www.agenziafarmaco.gov.it/it/responsabili". Reporting adverse reactions helps provide further information on the safety of this medicine.

5. HOW TO STORE TICALMA

Do not use the medicine after the expiry date stated on the packaging.
This medicine does not require any special storage conditions.
"Medicines should not be disposed of 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."
Keep the medicine out of the sight and reach of children.

6. OTHER INFORMATION

Composition
One 600 mg coated tablet contains:
Active ingredient: Valerian dry extract 100 mg.
Excipients: Starch, lactose, polyvinylpyrrolidone, talc, Aquacoat CPD, diethyl phthalate, sucrose,
arabic gum, titanium dioxide, carnauba wax.
Pharmaceutical form and contents
"100 mg coated tablets" (package containing 30 coated tablets of 600 mg)
Marketing Authorization Holder
Kelemata S.r.l., Corso Re Umberto, 20 - 10128 Turin A.I.C. 008290090
Manufacturer
Doppel Farmaceutici S.r.l. – 20089 Quinto de Stampi – Rozzano (Mi)
Kelemata S.r.l., Martellago (Ve) plant, via Castellana, 120