TINSET 30 mg Coated Tablet

Зміст інструкції

1. Tinset Adulti 30 mg tablets
   1. WHAT TINSET ADULTS IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING TINSET ADULTS
   3. PACKAGE CONTENTS AND OTHER INFORMATION
2. TINSET 25 mg/ml oral drops suspension
   1. WHAT TINSET IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING TINSET
   3. HOW TO USE TINSET
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE TINSET
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Tinset Adulti 30 mg tablets

Oxatomide

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 they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. WHAT TINSET ADULTS IS AND WHAT IT IS USED FOR

Tinset Adulti tablets contain the active substance oxatomide, which belongs to a group of
medicines called antihistamines.
Tinset Adulti tablets is used to prevent and treat allergic conditions such as:

• allergic rhinitis (hay fever)
• itchy skin rashes, chronic urticaria, eczema, atopic dermatitis
• allergic asthma
• conjunctivitis with follicular presence
• food allergies

Tinset Adulti tablets can be used together with other medicines to treat these types of allergies.
Tinset Adulti tablets should not be used to treat asthma attacks.
Tinset Adulti tablets is reserved for adults only.

2. WHAT YOU NEED TO KNOW BEFORE TAKING TINSET ADULTS

Do not take Tinset Adults tablets if you:

• are allergic to oxatomide (the active substance contained in Tinset Adults tablets), to cinnarizine (used to treat movement-related disorders) or to any of the other ingredients of this medicine (listed in section 6).
• suffer from liver problems. Contraindicated in children and adolescents under 18 years of age.

Warnings and precautions
Consult your doctor, pharmacist or nurse before taking Tinset Adults tablets:

• If you are taking Tinset Adults tablets to control asthma, the medicine you were already taking should not be stopped abruptly but reduced gradually.
• Your doctor will periodically check your liver function while you are taking Tinset Adults tablets. If, during treatment with Tinset Adults tablets, you develop

signs of abnormal liver function, treatment with Tinset Adults tablets should be
suspended and therapy with this medicine should not be restarted. Very rare cases of severe liver damage that can lead to death may occur.

• Abnormal movements, such as tremors or muscle spasms, have been reported during treatment with Tinset, if this happens to you, consult your doctor.
• Tinset Adults tablets must be used with caution in the elderly who may be more susceptible to its sedative effects and other adverse effects of treatment.

Children and adolescents
Tinset Adults tablets are contraindicated for use in children and adolescents under 18 years of
age.

Other medicines and Tinset Adults tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription. In particular, tell your doctor if
you are taking any of the following medicines:

• Any medicine containing alcohol; do not take these medicines while using Tinset Adults tablets. If in doubt, consult your doctor or pharmacist.
• Itraconazole or ketoconazole (used to treat fungal infections)
• Cimetidine (used to treat ulcers and heartburn)
• Medicines used to treat insomnia, depression, anxiety and psychotic conditions because Tinset may enhance their effect
• Antidepressants called monoamine oxidase inhibitors (MAO).

Tinset with food and drink
Do not drink alcohol while taking Tinset.

Laboratory tests
If you need to have a skin test for allergies, do not take Tinset for at least 3 days before the test,
because it may interfere with the results.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
The effects of Tinset Adults tablets on unborn babies or breastfed babies are
unknown, therefore the use of Tinset during pregnancy or during breastfeeding is not
recommended.
The effects of Tinset on fertility are unknown.

Driving and operating machinery
Tinset Adults tablets can cause drowsiness and lack of concentration, which may affect
your ability to drive or operate machinery. Alcohol can increase this effect.

Tinset Adults tablets contains lactose
If your doctor has diagnosed you with lactose intolerance, contact him before taking
this medicine.
Always take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, ask your doctor or pharmacist.
The recommended dose for adults is 1 tablet to be taken twice a day, after breakfast and after dinner.
Do not exceed the recommended daily dose.

If you take more Tinset Adults than you should
If you or someone else has accidentally taken too many Tinset Adults tablets, contact your doctor
or go to the nearest hospital, bringing with you, if possible, the packaging of the medicine. Symptoms of
overdose include muscle spasms, hyperexcitability, agitation, altered
heart function, altered consciousness and coma.

If you forget to take Tinset Adults tablets
Take a tablet as soon as possible, unless it is almost time to take the next tablet.
If the time to take the next tablet is near, take the tablet at the usual time.
Do not take a double dose to make up for the forgotten tablet.
If you have any questions about using this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everyone
experiences them.
STOP taking Tinset Adults tablets and consult a doctor if you experience the following symptoms
which may be signs of an allergic reaction:

• swelling of the face, lips, throat or tongue
• difficulty breathing
• skin rash.

Possible side effects are:

Very common(may affect more than 1 in 10 people)

• Drowsiness

Common(may affect up to 1 in 10 people)

• Increased appetite
• Feeling tired
• Headache
• Sedation
• Dry mouth

Uncommon(may affect up to 1 in 100 people)

• Weight gain
• Changes in appetite
• Nervousness
• Restlessness
• Irritability
• Insomnia
• Inability to concentrate
• Dizziness
• Shortness of breath
• Nausea (feeling unwell)
• Vomiting (being sick)
• Stomach pain
• Indigestion (dyspepsia)
• Constipation
• Abdominal pain
• Chest discomfort
• Urinary retention (difficulty urinating)
• Skin rash
• Hives

Very rare(may affect up to 1 in 10,000 people)

• Anemia and other blood problems
• Hypersensitivity and shock
• Decreased appetite
• Psychiatric disorders (hallucinations, agitation, apathy, confusion, disorientation, nightmares, sleep disorders, aggression)
• Blurred vision, abnormal dilation of the pupil and other vision problems
• Tinnitus (ringing in the ears), hearing loss
• Changes in heart rate and rhythm, palpitations (irregular heartbeat)
• Flushing, low blood pressure (hypotension)
• Nosebleeds, bronchial constriction, dry nose
• Heartburn, gastroesophageal reflux, esophagitis, diarrhea
• Liver damage, hepatitis, jaundice
• Itching (pruritus) and swelling (edema) of the skin, photosensitivity (increased sensitivity of the skin to light), eczema
• Excessive sweating
• Severe skin rash with blisters and peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Stiffness or weakness of the muscles, difficulty walking, stiff neck
• Change in urine color
• Breast enlargement (in men) or milk production from the breasts not due to childbirth or breastfeeding
• Fever, chills, fluid retention, abnormal sense of touch
• Changes in blood and liver test results

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the system
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.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and blister after
EXP:. The expiry date refers to the last day of that month.
Do not throw away any medicines 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 Tinset Adulti tablets contain
The active substance is oxatomide. Each tablet contains 30 mg of oxatomide.
The other ingredients are: lactose (120 mg per tablet), corn starch, microcrystalline cellulose,
povidone, precipitated silica, magnesium stearate

See end of section 2 for further information on lactose.

Description of the appearance of Tinset Adulti tablets and package contents
Tinset Adulti 30 mg tablets are round, white, flat, with a break line engraved on
one side and “30” engraved on the other side. They are packaged in blisters containing 30 tablets.

Marketing Authorisation Holder
GRÜNENTHAL ITALIA S.r.l.
Via Carlo Bo, 11 – 20143 Milano
Italy

Manufacturer
FARMACEUTICI FORMENTI S.p.A.
Origgio (VA) production site
Via Di Vittorio 2
Origgio (VA) - Italy

TINSET 25 mg/ml oral drops suspension

Oxatomide

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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. WHAT TINSET IS AND WHAT IT IS USED FOR

Tinset contains the active substance oxatomide, which belongs to a group of medicines called
antihistamines.
Tinset is used to prevent and treat allergic conditions such as:

• allergic rhinitis (hay fever)
• Itchy skin rashes, eczema (chronic urticaria, atopic dermatitis)
• Allergic asthma
• Conjunctivitis with the presence of follicles
• Food allergies

Tinset can be used together with other medicines to treat these types of allergies.
Tinset should not be used to treat asthma attacks.
Tinset 25 mg/ml oral drops suspension is used in adults, adolescents and children aged
1 year or older.

2. WHAT YOU NEED TO KNOW BEFORE TAKING TINSET

Do not take Tinset if:

• you or your child are allergic to oxatomide (the active substance contained in Tinset), to cinnarizine (used to treat movement disorders), or to any of the other ingredients of this medicine (listed in section 6).
• your child is less than 1 year old, or you or your child suffer from liver disorders.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tinset:

• If you or your child are taking Tinset to control asthma, the medicine you were already taking should not be stopped immediately but reduced gradually.
• Your doctor will periodically check the function of your liver or your child's liver while you are taking Tinset. If, during treatment with Tinset, you or your child develop signs of abnormal liver function, treatment with Tinset should be stopped and therapy with this medicine should not be resumed. Very rare cases of severe liver damage may occur, which can lead to death.
• Abnormal movements, such as tremors or muscle spasms, have been reported during treatment with Tinset; if this happens to you or your child, tell your doctor.
• Tinset should be used with caution in the elderly, who may be more susceptible to the sedative effects and other adverse effects of treatment.

Children and adolescents
Tinset should not be used in children under 1 year of age. Caution is recommended in
children between 1 and 6 years of age and especially in those between 12 and 24 months.
Always use this medicine exactly as your doctor or pharmacist has told you, especially in
children.

Other medicines and Tinset
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription. In particular, tell your doctor
if you are taking any of the following medicines:

• Any medicine containing alcohol; do not take these medicines while you are using Tinset. If in doubt, ask your doctor or pharmacist.
• Itraconazole or ketoconazole (used to treat fungal infections)
• Cimetidine (used to treat ulcers and heartburn)
• Medicines used to treat insomnia, depression, anxiety or psychotic conditions because Tinset may enhance their effect
• Antidepressants called monoamine oxidase inhibitors (MAO)

Tinset with food and drink
Do not drink alcohol while taking Tinset.

Laboratory tests
If you are going to have a skin test for allergies, do not take Tinset 3 days before the test, because
it may interfere with the results.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding with milk
ask your doctor or pharmacist for advice before taking this medicine.
The effects of Tinset on the baby before birth or on the breastfed baby are unknown,
therefore the use of Tinset during pregnancy or breastfeeding is not recommended.
The effects of Tinset on fertility are unknown.

Driving and operating machinery
Tinset can cause drowsiness and lack of concentration, which may affect your
ability to drive or operate machinery. Alcohol can increase this effect.
Tinset 25 mg/ml oral drops suspension contains:

• methyl parahydroxybenzoate and propyl parahydroxybenzoatewhich may cause allergic reactions (including delayed reactions).
• less than 1 mmol (23 mg) of sodiumper dose, i.e. essentially ‘sodium-free’.

3. HOW TO USE TINSET

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Adults:30 drops (equivalent to 30 mg) to be taken twice a day, after breakfast and after
dinner.
Children aged 1 year or over (weighing from 12 kg to 48 kg): 1 drop for every 2 kg of weight,
twice a day after breakfast and after dinner as specified below:

Child's weightNumber of dropsHow many times a day
12 kg 6 drops 2 times a day
14 kg 7 drops 2 times a day
16 kg 8 drops 2 times a day
20 kg 10 drops 2 times a day
24 kg 12 drops 2 times a day
28 kg 14 drops 2 times a day
32 kg 16 drops 2 times a day
36 kg 18 drops 2 times a day
40 kg 20 drops 2 times a day
44 kg 22 drops 2 times a day
48 kg 24 drops 2 times a day
The doctor will tell you the dose to give to the child if:

• They are 1 year old or more than 1 year old and weigh less than 12 kg
• They weigh more than 48 kg.

Do not take or give more drops than recommended, as an overdose can cause serious side
effects, especially in children.

• Give your child the number of drops calculated based on their weight
• If you are not sure of the number of drops to give, ask your doctor or pharmacist

Warning: an overdose can lead to serious side effects, especially in children,
therefore it is necessary to strictly follow the recommended dosage. To avoid an accidental
overdose, give your child the number of drops calculated based on the child's weight.
This medicine has a similar appearance to milk and may attract children's attention, so when you give
Tinset to your child, follow these rules:

• Keep the open bottle out of the reach and sight of children while you are giving the drops
• Screw the cap with the dropper tightly onto the bottle immediately after giving the medicine
• Store the bottle closed in a suitable place, out of the sight and reach of children

Keep the open bottle out of the reach of children during administration and make sure that
the child-resistant closure is properly closed after use. If the bottle is not closed
correctly (see below) the cap is no longer child-resistant.

How to use Tinset oral drops suspension
Shake the bottle well before each use.
The bottle cap has a safety mechanism: if your child tries to open the bottle,
they will have difficulty. You must close the bottle carefully as explained below, so that your
child has difficulty opening it.

	To open, push the plastic dropper cap firmly downwards, then unscrew. o
	c a After use, put the dropper cap back into the bottle. To close, push with m firmly downwards and simultaneously screw on.
	r a To make sure the safety mechanism has engaged correctly, rotate the cap counterclockwise without pressing and check that the bottle does not open. F

If you use more Tinset 25 mg/ml oral drops suspension than you should
If you or someone else has accidentally taken too many drops, contact your doctor or go to the nearest
hospital, bringing with you, if possible, the packaging. Symptoms of overdose include
muscle spasms, hyperexcitability, agitation, altered heart function, altered
consciousness and coma.

If you forget to take Tinset 25 mg/ml oral drops suspension
Take the dose as soon as possible unless it is close to the time to take another dose. If the time to
take the next drops is near, take the drops at the usual time. Do not take a double dose to
make up for forgotten drops.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Tinset and consult a doctor if you experience the following symptoms, which may
be signs of an allergic reaction:

• swelling of the face, lips, throat or tongue
• difficulty breathing
• skin rash.

Possible side effects are:

Very common(may affect more than 1 in 10 people)

• Drowsiness

Common(may affect up to 1 in 10 people)

• Increased appetite
• Feeling tired
• Headache
• Sedation
• Dry mouth

Uncommon(may affect up to 1 in 100 people)

• Weight gain
• Changes in appetite
• Nervousness
• Restlessness
• Irritability
• Insomnia
• Inability to concentrate
• Dizziness (vertigo)
• Shortness of breath
• Nausea (feeling unwell)
• Vomiting (feeling sick)
• Stomach pain
• Indigestion (dyspepsia)
• Constipation
• Abdominal pain
• Chest discomfort
• Urinary retention (difficulty urinating)
• Skin rash
• Hives

Very rare(may affect up to 1 in 10,000 people)

• Anemia and other blood disorders
• Hypersensitivity and shock
• Decreased appetite
• Psychiatric disorders (hallucinations, agitation, apathy, confusion, disorientation, nightmares, sleep disorders, aggression)
• Blurred vision, abnormal pupil dilation and other vision problems
• Tinnitus (ringing in the ears), hearing loss
• Changes in heart rate and rhythm, palpitations (irregular heartbeat)
• Hot flushes, low blood pressure (hypotension)
• Nosebleeds, bronchial constriction, dry nose
• Heartburn, gastro-esophageal reflux, esophagitis, diarrhea
• Liver damage, hepatitis, jaundice
• Itching (pruritus) and swelling (edema) of the skin, photosensitivity (increased sensitivity of the skin to light), eczema
• Excessive sweating
• Severe skin rash with blisters and peeling skin (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Stiffness or weakness of muscles, difficulty walking, stiff neck
• Change in urine color
• Breast enlargement (in men), milk production from the breast not due to childbirth or breastfeeding
• Fever, chills, fluid retention, abnormal sense of touch
• Changes in blood and liver test results

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the system
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 TINSET

Keep this medicine out of the sight and reach of children.
Make sure the child-resistant cap is correctly closed after use.
Do not use this medicine after the expiry date which is stated on the pack or bottle.
The expiry date refers to the last day of that month.
After opening, Tinset oral drops suspension must be used within 3 months.
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 AND OTHER INFORMATION

What Tinset 25 mg/ml oral drops suspension contains

• The active substance is oxatomide. Tinset 25 mg/ml oral drops suspension contains 2.6 g of oxatomide hydrate (equivalent to 2.5 g of oxatomide) per 100 ml. One drop is equivalent to 1 mg of oxatomide.
• The other components are microcrystalline cellulose and carmellose, povidone, polysorbate 20, methyl parahydroxybenzoate (180 mg per 100 ml), propyl parahydroxybenzoate (20 mg per 100 ml), sodium saccharin (50 mg per 100 ml), purified water. See the end of paragraph 2 for more information on methyl parahydroxybenzoate, propyl para-hydroxybenzoate and sodium..

Description of the appearance of Tinset 25 mg/ml oral drops suspension and package contents
Tinset 25 mg/ml oral drops suspension is a white suspension packaged in an amber glass bottle
of 30 ml with a dropper and child-resistant closure.

Marketing Authorisation Holder
GRÜNENTHAL ITALIA S.r.l.
Via Carlo Bo, 11 - 20143 Milano
Italy

Manufacturer
FARMACEUTICI FORMENTI S.p.A.
Manufacturing site: Origgio (VA)
Via Di Vittorio 2
Origgio (VA) - Italy
In case of systemic absorption (into the blood) the effect of the medicine may be potentiated if you are
taking medicines used to treat insomnia, depression, anxiety or psychotic conditions.

Marketing Authorisation Holder