Rinasek tablets (60mg+2.5mg) a10

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Rinasek®
60 mg + 2.5 mg, tablets
pseudoephedrine, triprolidine
Read this leaflet carefully before you start taking this medicine because it contains information
that are important to you.
 Always take this medicine exactly as stated in this instruction or as explained to you
Your doctor or pharmacist.
 Save the instructions. You may need to read it again.
 If you have additional questions or need advice, contact your pharmacist.
 If you experience any side effects, contact your doctor or pharmacist. This
includes any side effects not listed in this guide. See section 4.
 If you do not feel better or feel worse after 5 days, you must contact your doctor.
In this guide you will read:
1. What is Rinasek and what is it for?
2. What you need to know before taking Rinasek
3. How to take Rinasek
4. Possible side effects
5. How to store Rinasek
6. Contents of the package and other information
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1. What is Rinasek and what is it for?
The drug Rinasek contains the active substances pseudoephedrine and triprolidine. It is used to relieve symptoms
colds, flu and allergies including sneezing, runny nose, watery eyes and nasal and sinus congestion. These
tablets contain pseudoephedrine hydrochloride which is a decongestant that relieves nasal and sinus congestion and triprolidine hydrochloride belongs to a group of medicines called antihistamines used to treat allergy symptoms
like sneezing, runny nose and watery eyes.
Rinasek tablets are used to treat:
- allergic rhinitis (inflammation of the mucous membrane of the nose caused by an allergy)
- vasomotor rhinitis (inflammation of the nasal mucosa of a non-allergic nature)
– colds (sneezing).
This medicine is intended for use in adults and children 12 years of age and older.
You must contact your doctor if you do not feel better or if you feel worse after 5 days.
2. What you need to know before taking Rinasek
You must not take Rinasek:
- if you are allergic (hypersensitive) to triprolidine and pseudoephedrine or to any of the excipients
substances of this medicine (listed in section 6)
- if you have diabetes (diabetes mellitus) or severe impairment of kidney function
- if you have elevated thyroid function (hyperthyroidism)
- if you have closed-angle glaucoma (increased pressure in the eye)
- if you have a pheochromocytoma (a tumor that affects the heart and blood pressure)
- if you have hypertension (high blood pressure) or heart and blood vessel disease or if you are taking
drugs from the group of beta-blockers.
- if you have lung disease or breathing problems, and the risk of developing lung weakness
(respiratory insufficiency)
- if you are taking or have taken in the past two weeks medicines for the treatment of depression, such as
monoamine oxidase inhibitors (MAOIs) or reversible monoamine oxidase inhibitors (RIMAs)
- if you are taking other cough medicines or other cold medicines (other sympathomimetics).
This medicine should not be taken by children under 12 years of age.
If any of the above applies to you, consult your doctor or pharmacist before taking
the Rinasek drug.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rinasek if:
– you have kidney disease and/or severe liver disease
- you are susceptible to angle-closure glaucoma (increased pressure in the eyes)
- you have reduced blood flow through the arteries or veins (occlusive vascular disease)
- you are on therapy for thyroid disease
- you have problems with the prostate (difficulty urinating or the need to urinate frequently)
– you are addicted to alcohol
– you suffer from epilepsy
– you have asthma, chronic bronchitis or emphysema of the lungs
If you experience any of the following, stop taking this medicine immediately and contact your doctor
tell your doctor:
 widespread redness and pustules (small changes on the skin with purulent content), followed by
fever (see section 4)
 sudden abdominal pain, the appearance of blood in the stool or bleeding from the stool or diarrhea due to inflammation of the colon
intestines (ischemic colitis). If you experience these symptoms of the digestive system, stop immediately
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to use Rinasek, contact your doctor or seek immediate medical help
(see section 4).
 sudden severe headache, nausea, vomiting, confusion, muscle spasms and visual disturbances.
 hallucinations (deception of the senses)
 Anxiety and sleep disturbance
The drug Rinasek, tablets, can cause drowsiness.
This medicine should not be used to sedate a child.
This drug may result in a positive anti-doping test.
The doctor or pharmacist is obliged to check that medicines containing sympathomimetics are not administered
at the same time, in several ways, e.g. oral and local (nose, ear and eye solutions).
Rinasek can have a stimulating effect on the central nervous system, which can cause insomnia.
agitation, hyperpyrexia (increased body temperature), tremors (shaking) and epileptiform convulsions
(muscle spasm attacks). Caution is necessary in people suffering from epilepsy.
Other medicines and the medicine Rinasek
Inform your doctor or pharmacist if you are taking, have recently taken or may take any
what other medicines.
Tell your doctor if you are taking:
 sedatives (medicines used in the therapy of anxiety and tension)
 antihypertensives (medicines used to treat high blood pressure such as guanethidine, reserpine, methyldopa,
adrenergic blockers, debrisoquine, bretylium, betanidine)
 stimulants or appetite suppressants and drugs used in the therapy of congestion and asthma
(sympathomimetics)
 tricyclic antidepressants (used in the treatment of mood disorders)
 moclobemide (used in the treatment of mood disorders)
 cardiotonic glycosides (medicines used in the therapy of heart rhythm control or heart contractions
such as digoxin
 ergot alkaloids (medications used in migraine therapy such as ergotamine and methylsergide)
 oxytocin (a drug used to induce contractions during childbirth)
 anticholinergics (medicines used in the treatment of convulsions or spasms such as atropine)
 hypnotics (hypnotics including barbiturates)
 opioid analgesics (medicines used against pain such as codeine, tramadol, morphine)
 antipsychotics (medications used in the therapy of mood disorders)
 monoamine oxidase inhibitors (used in the treatment of mood disorders)
 anesthetics (halogens - can affect the heart and lead to arrhythmias)
If you are not sure about any medicine you are taking, show the box or bottle of medicine to your pharmacist.
Taking Rinasek with food, drinks and alcohol
During treatment with Rinasek, you must not consume alcoholic beverages. Alcohol enhances the effect of the drug
Rinasek affecting the reduction of attention and mental abilities.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you are pregnant or are planning to become pregnant, contact your doctor or
pharmacist for advice before taking this medicine.
Do not take Rinasek during pregnancy without the advice of your doctor.
Rinasek is excreted in small amounts in breast milk.
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Do not take Rinasek during breastfeeding without the advice of your doctor.
If you have additional questions, please contact your doctor.
Driving vehicles and operating machines
This medicine can cause dizziness, drowsiness, decreased alertness and hearing impairment. If you like
If these side effects occur, do not drive or operate machinery.
Avoid the use of alcoholic beverages and other drugs that can cause drowsiness, because in this case
increases the likelihood of these side effects.
Rinasek contains lactose monohydrate
Rinasek contains lactose monohydrate. In case of intolerance to certain sugars, consult your doctor
before using this medicine.
3. How to take Rinasek
Always take this medicine exactly as stated in this leaflet or as explained to you by your doctor
or a pharmacist. If you are not sure, check with your doctor or pharmacist.
Recommended dose for adults and children over 12 years old: 1 tablet every 4-6 hours, maximum 4 tablets per day.
Leave at least 4 hours between doses.
Do not take more than 4 tablets in 24 hours.
Rinasek tablets are intended for oral use (taken by mouth).
Use in children under 12 years of age
This medicine must not be given to children under 12 years of age. Children aged 6 to 12 should use the drug Rinasek (30
mg/5 mL + 1.25 mg/5 mL), syrup.
Seniors.
In the elderly, the usual adult dose has been shown to be appropriate
Caution is required in case of severe impairment of kidney and/or liver function.
If you have taken more Rinasek than you should
If you have taken more tablets than recommended (overdose) or someone else
accidentally took your medicine, contact your doctor, pharmacist or nearest health facility immediately.
Symptoms of an acute overdose are drowsiness, fatigue, dizziness, difficulty walking, weakness, muscle weakness,
difficulty breathing, dryness of the skin and mucous membranes, rapid heart rate, increased blood pressure, increased body temperature
temperature, hyperactivity, irritability, heart palpitations, cramps and difficulty urinating, increased blood sugar,
decreased concentration of potassium in the blood, insomnia, nervousness, agitation, confusion, delirium, psychosis,
convulsions (muscle spasms), hand tremors, bleeding in the brain, drowsiness in children, dilated pupils,
slowed heart rate, supraventricular and ventricular arrhythmias, dysarrhythmia, heart attack, hypertensive crisis,
nausea, vomiting, intestinal necrosis, muscle breakdown, acute renal failure, urinary disorder,
anticholinergic syndrome (pupil dilation, flushing, increased body temperature, dry mouth,
urinary retention, decreased bowel motility), decreased blood pressure, sensory illusions (hallucinations).
If you forget to take Rinasek
Do not take a double dose to make up for a missed dose.
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If you missed a dose of the medicine, take it as soon as you can and continue taking the therapy
according to the schedule for that day, taking care to take each subsequent dose with a time gap of at least
4 hours, not more than 4 tablets in 24 hours. However, if it is almost time for the next dose,
continue taking the drug according to the recommended regimen.
If you have any further questions about the use of 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.
patients taking this medicine.
If you experience any of the following side effects, stop taking this medicine immediately
seek medical attention:
 sudden appearance of elevated body temperature, redness of the skin, or numerous blue pustules
(possible symptoms of acute generalized exanthematous pustulosis-AGEP), may occur in the first
two days of therapy with this medicine (see section 2)
 sudden pain in the abdomen, appearance of blood in the stool or bleeding from stool and diarrhea (inflammation due to
insufficient blood flow to the large intestine - ischemic colitis)
 sudden severe headache, nausea, vomiting, confusion, convulsions and visual disturbances
 swelling of the face, lips, mouth, tongue, throat, which can cause difficulty in swallowing and breathing
 feeling tired, unexpected bruising and bleeding or infection (such as a cold)
 allergic reactions including rashes such as hives (which can be severe and include
blisters and peeling skin) itching and rash
 sensory delusions (hallucinations), paranoid delusions and convulsions (epileptic attacks, convulsions).
If you experience any of the above, stop taking this medicine and talk to your doctor
doctor:
 agitation or sleep disturbance
 fast or irregular heartbeat or subjective feeling of heart palpitations (palpitations)
 difficult urination (especially in men with prostate problems)
Other side effects that may occur:
Very common side effects (may occur in more than 1 in 10 patients taking the medicine):
 headache
Common side effects (may occur in up to 1 in 10 patients taking the medicine):
 insomnia, nervousness, dizziness
 drowsiness
 blurred vision
 thick secretions, dry mouth, nausea and stomach pain
Rare side effects (may occur in up to 1 in 1000 patients taking the medicine):
 confusion
 depression
 stiffness, tremors or speech disorder
 low blood pressure
 blood disorders
 liver disorders
Frequency not known: cannot be estimated from the available data:
 stroke
 heart attack/reduced blood flow to the heart which can cause discomfort or pain in the chest, neck,
back, jaw, shoulders and arms (known as angina), rapid heartbeat
 agitation, anxiety, irritability or a feeling of indescribable happiness
 tingling and tingling of hands and feet
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 high blood pressure
 nosebleeds, dry nose and throat
 vomiting or abdominal pain
 pain during urination
 fatigue
 very high body temperature
Reporting adverse reactions
If you experience any unwanted reaction, you should inform your doctor or pharmacist.
This includes any possible side effects that are not listed in this guide. By signing up
adverse reactions can help evaluate the safety of this medicine. They suspect unwanted reactions
you can report to the Agency for Medicines and Medical Devices of Serbia (ALIMS):
Agency for Medicines and Medical Devices of Serbia
National Center for Pharmacovigilance
Vojvode Stepe 458, 11221 Belgrade
Republic of Serbia
website: www.alims.gov.rs
e-mail: nezeljene.reakcije@alims.gov.rs
5. How to store Rinasek
Keep the medicine out of the sight and reach of children.
You must not use Rinasek after the expiration date indicated on the package after: "Expired by". Date
the expiration date refers to the last day of the specified month.
Store at a temperature of up to 25ºC in the original packaging, in order to protect from light and moisture.
Unusable medicines are handed over to the pharmacy where the notice that they are to be collected is displayed in that pharmacy
unusable medicines from citizens. Unusable medicines must not be thrown into the sewer or together with
communal waste. These measures will help protect the environment.
6. Contents of the package and other information
What Rinasek contains
The active substances are: triprolidine hydrochloride and pseudoephedrine hydrochloride.
One tablet contains: pseudoephedrine hydrochloride 60 mg
triprolidine hydrochloride 2.5 mg i

Auxiliary substances are: lactose, monohydrate; starch, corn; povidone (K25); magnesium stearate.
What Rinasek looks like and the contents of the package
Round, flat tablets, white to off-white, debossed on one side with a score line, the letter M and
number 1.
The tablet can be divided into equal doses.
The inner packaging is a PVC//AL blister containing 10 tablets.
The outer packaging is a collapsible cardboard box containing one blister (total of 10 tablets) and Instructions for use
medicine.
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License holder and manufacturer
HEMOFARM AD VRŠAC, Beogradski put bb, Vršac, Republic of Serbia
This instruction was last approved
May, 2020.
Mode of administration of the drug:
The drug is issued without a doctor's prescription.
License number and date:
515-01-03023-19-001 from 06.05.2020.