BABY 2,4 G/100 ML + 0,015 G/100 ML Syrop

Treść ulotki

1. BABY RINOLO C.M. 2.4 g/100 ml + 0.015 g/100 ml syrup
   1. What is BABY RINOLO C.M. and what is it used for
   2. What you need to know before using BABY RINOLO C.M.
   3. How to use BABY RINOLO C.M.
   4. Possible side effects
   5. How to store BABY RINOLO C.M.
   6. Contents of the pack and other information

BABY RINOLO C.M. 2.4 g/100 ml + 0.015 g/100 ml syrup

Paracetamol, Chlorphenamine maleate

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 could be harmful.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What BABY RINOLO C.M. is and what it is used for
• 2. What you need to know before using BABY RINOLO C.M.
• 3. How to use BABY RINOLO C.M.
• 4. Possible side effects
• 5. How to store BABY RINOLO C.M.
• 6. Contents of the pack and other information

1. What is BABY RINOLO C.M. and what is it used for

BABY RINOLO C.M. is a medicine that contains 2 active ingredients: paracetamol, which is an
analgesic and antipyretic (reduces fever), and chlorphenamine maleate, which is an
antihistamine.
BABY RINOLO C.M. is used in association with other medicines (adjunctive treatment), in
cases of:

• fever associated with nasal or throat problems (upper respiratory tract);
• inflammation of the nasal cavities (acute and subacute sinusitis).

2. What you need to know before using BABY RINOLO C.M.

Do not use BABY RINOLO C.M. if:

• you are allergic to paracetamol and chlorphenamine or to any of the other ingredients of this medicine (listed in section 6);
• your child is under three years of age;
• you have had symptoms due to a disease known as favism or fava bean disease, which causes a decrease in red blood cells (glucose-6-phosphate dehydrogenase deficiency);
• you suffer from hemolytic anemia, a disease that destroys red blood cells;
• you have severe liver problems (hepatobiliary insufficiency);
• you have severe heart problems;
• you have an obstruction of the stomach or intestine (pyloro-duodenal obstruction);
• you suffer from bronchial asthma.

Warnings and precautions
Consult your doctor before using BABY RINOLO C.M. if:

• you have increased thyroid function (hyperthyroidism);
• you have diabetes;
• you have heart problems;
• you have kidney problems (renal insufficiency);
• you urinate little (urinary retention);
• you have liver problems (hepatic insufficiency);
• you suffer from epilepsy;
• you have been following a poor diet for a long time (malnutrition);
• you chronically abuse alcohol or consume it excessively (3 or more alcoholic beverages per day);
• you have a severe infection (sepsis).

During treatment with paracetamol, before taking any other medicine, check that it does not contain the same active ingredient, as if paracetamol is taken in high doses, serious side effects may occur.
During treatment with BABY RINOLO C.M., immediately inform your doctor if you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients in these situations, a serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in combination with flucloxacillin. The symptoms of metabolic acidosis may include: severe difficulty breathing with rapid, deep breathing, drowsiness, nausea and vomiting.
During treatment with paracetamol, your doctor will monitor your respiratory function.

Other medicines and BABY RINOLO C.M.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines
Do not use BABY RINOLO C.M. with other medicines that contain paracetamol or that reduce fever and pain.
This is particularly important if you are taking:

• Antidepressants (medicines used for depression) such as tricyclics and monoamine oxidase inhibitors (MAOIs);
• sedatives such as barbiturates;
• neuroleptics (medicines used against psychoses);
• anti-inflammatory drugs such as indometacin (used to treat rheumatic diseases);
• antivirals (medicines used to treat diseases caused by viruses) such as zidovudine;
• anxiolytics (medicines used for anxiety);
• hypnotics and sedatives (medicines that induce sleep);
• opioids and NSAIDs (medicines used for pain);
• cholestyramine (used to lower cholesterol in the blood);
• metoclopramide (used to treat nausea and vomiting);
• anticoagulants (medicines that delay blood clotting) such as warfarin or other coumarins;
• antiepileptics (medicines used to treat epilepsy) such as glutethimide, phenobarbital, carbamazepine;
• rifampicin and isoniazid (antibiotics used for the treatment of tuberculosis (lung disease);
• cimetidine medicine used to treat peptic ulcer (a lesion of the stomach);
• probenecid (medicine used in gout);
• flucloxacillin (antibiotic), due to a serious risk of alterations in the blood and fluids (called metabolic acidosis with high anion gap) which must be treated urgently (see section 2).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, BABY RINOLO C.M. can be used during pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever and to take it for the shortest possible time.
Contact your doctor if the pain and/or fever does not decrease or if you need to take the medicine more often.

Driving and operating machinery
BABY RINOLO C.M. may moderately impair the ability to drive vehicles and operate machinery.

BABY RINOLO C.M. contains:

• Sucrose. If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine;
• Sorbitol. It can cause gastrointestinal problems and have a mild laxative effect;
• Sodium metabisulfite. Rarely it can cause severe hypersensitivity reactions and bronchospasm;
• Methyl-para-hydroxybenzoate and propyl-para-hydroxybenzoate. They can cause allergic reactions (even delayed); Ethanol. This medicine contains 175 mg of ethanol per 2.5 ml dose, which is equivalent to approximately 29 mg/kg for a 6 kg child. The amount of ethanol in 2.5 ml of BABY RINOLO C.M. is equivalent to less than 5 ml of beer or 2 ml of wine. The amount of alcohol in this medicine is unlikely to have an effect on adults and adolescents and its effects in children are not evident. Some effects may occur in small children, for example feeling sleepy. The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines. If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine.
• If you have an alcohol dependence, talk to your doctor before taking this medicine. Sodium. This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’;
• Propylene Glycol. If the child is less than 5 years of age, talk to your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.

3. How to use BABY RINOLO C.M.

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

Children over 3 yearsof ageand weighing more than 6 kg
The recommended dose is calculated based on the child's weight:

• from 6 to 10 Kg: 2.5 ml every 4 hours;
• from 10 to 20 Kg: 5 ml every 6 hours;
• over 20 Kg: 5 ml every 4 hours.

Do not administer to children under three years of age.
Do not administer for more than five days.

Method of administration
BABY RINOLO C.M. must be taken orally. To avoid
stomach upset, take this medicine after meals.
To take the correct dose:

• 1. Open the bottle by pressing and turning the cap simultaneously (Fig. 1).
• 2. Use the measuring cup with graduations at 2.5 ml, 5 ml and 7.5 ml or the dosing syringe with graduations at 2.5 ml and 5 ml found in the package to take the correct dose.
• 3. After taking the dose, close the bottle by pressing down firmly and screwing on the cap (Fig.
• 2) and wash the measuring cup or dosing syringe thoroughly with water.

If you use more BABY RINOLO C.M. than you should, you may notice: nausea, vomiting, abdominal pain, deep sleep (lethargy), sweating, serious damage to the liver, kidneys or blood,
heart changes and inflammation of the pancreas (pancreatitis).
If you use more BABY RINOLO C.M. than you should, inform your doctor immediately or
go to the nearest hospital, as appropriate measures may be necessary.

If you forget to use BABY RINOLO C.M.
Do not use a double dose to make up for a missed dose.

If you stop the treatment with BABY RINOLO C.M.
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.

Stop taking BABY RINOLO C.M. and contact your doctor immediately if any of the following occur:

• allergic reactions (hypersensitivity) including severe ones, associated with swelling of the throat (laryngeal edema) of the face, eyes, lips, mouth, tongue or throat that can cause difficulty in breathing (angioedema), sudden drop in blood pressure (anaphylactic shock);
• severe skin reactions, which manifest with redness, blister or pus formation and exfoliation (e.g. erythema multiforme, acute pustulosis exanthematica, Stevens-Johnson syndrome and toxic epidermal necrolysis).

Inform your doctor if any of the following side effects occur:

Rare side effects(may affect up to 1 in 1,000 people)

• more or less sudden appearance of skin lesions, for example, changes in color in patches or widespread (skin reactions), redness (maculopapular rash, erythema),

urticaria, itching;

• dry mouth, stomach or intestinal disorders (gastrointestinal reaction) such as: vomiting, difficulty evacuating (constipation), nausea;
• dizziness, headache, sedation, drowsiness, confusion, convulsions, agitation, anxiety, nervousness, irritability, insomnia, psychotic disorder;
• alteration of facial movements (dyskinesia);
• dryness of the nose, decreased bronchial secretions, denser bronchial secretions;
• decrease in red blood cells (anemia), decrease in the number of white blood cells (leukopenia), decrease in the number of platelets (thrombocytopenia), reduced number of granulocytes (agranulocytosis);
• difficulty breathing or feeling of tightness in the chest;
• double vision (diplopia), problems focusing images (accommodation);
• alteration of liver function, liver inflammation (hepatitis);
• increased blood pressure (hypertension), increased heart rate (tachycardia), feeling of heart racing (palpitation);
• presence of blood in the urine (hematuria), failure to pass urine (anuria, urinary retention) or difficulty urinating (dysuria) kidney inflammation (interstitial nephritis) or alterations in kidney function (acute renal failure). Very rare side effects(may affect less than 1 in 10,000 people):
• Severe skin reactions. Side effects with unknown frequency(cannot be estimated from available data):
• severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
“ http://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 BABY RINOLO C.M.

Keep this medicine out of the sight and reach of children.
After the first opening of the bottle, use the medicine within 6 months.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in waste water 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 BABY RINOLO C.M. contains
The active ingredients are: paracetamol and chlorphenamine maleate.
100 ml of syrup contains: 2.4 g of paracetamol and 0.015 g of chlorphenamine maleate.
The other ingredients are: sucrose, saccharin, sodium metabisulfite, liquid sorbitol, methyl-
p-hydroxybenzoate, propyl-p-hydroxybenzoate, sodium monobasic phosphate monohydrate, sodium
dibasic phosphate dodecahydrate, erythrosine (E 127), propylene glycol, ethanol, orange essence,
diethanolamine, purified water.

Description of the appearance of BABY RINOLO C.M. and contents of the pack
BABY RINOLO C.M. is a syrup available in a 120 ml bottle, equipped with a measuring cup with
graduations of 2.5 ml, 5 ml and 7.5 ml and a dosing syringe with graduations of 2.5 ml and 5 ml.

Marketing Authorisation Holder
Bruno Farmaceutici S.p.A.
Via delle Ande, 15
00144 Roma

Manufacturer
VAMFARMA S.R.L.
Via Kennedy, 5
26833 Comazzo (LO)