Stopcold 5 mg/120 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

StopCold 5 mg/120 mg prolonged-release tablets

(cetirizine dihydrochloride, pseudoephedrine hydrochloride)

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What StopCold is and what it is used for

StopCold is an antiallergic agent belonging to a class of compounds known as antihistamines combined with a decongestant.

StopCold is used for the treatment of nasal congestion and other symptoms associated with chronic or seasonal allergic rhinitis (such as nasal itching, eye itching, sneezing, and nasal discharge and congestion).

2. What you need to know before taking StopCold

Do not take StopCold:

• If you are allergic to the active substances, ephedrine, any piperazine, or any of the other components of this medicine (listed in section 6).
• If you have very high blood pressure (severe hypertension) or uncontrolled hypertension, serious heart problems, or irregular heart rhythms (severe arrhythmias).
• If you are being treated with migraine medications containing dihydroergotamine.
• If you have uncontrolled hyperthyroidism.
• If you are taking antidepressants (of the class known as monoamine oxidase inhibitors).
• If you have severe, acute (sudden) or chronic (long-term) kidney disease, kidney failure, or end-stage kidney disease (patients with Glomerular Filtration Rate (GFR) below 15 ml/min), or prostate enlargement.
• If you have difficulty urinating (urinary retention).
• If you have closed-angle glaucoma.
• If you have a history of, or are at high risk of, stroke.
• If you have a tumor of the adrenal gland (called a pheochromocytoma).
• If you are under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before taking StopCold if:

• You have diabetes, hyperthyroidism, high blood pressure, rapid heartbeat, irregular heart rhythm, heart problems (heart failure), liver problems, or if you are elderly.

• You have kidney problems: a lower dose will be administered depending on the severity of your kidney condition; your doctor will advise you on the appropriate dose.

• You are taking sympathomimetic medicines (decongestants, appetite suppressants, stimulants), tricyclic antidepressants, or cardiac glycosides (see Use with other medicines).

• You consume alcohol or any other central nervous system depressant, as this may impair your ability to perform tasks.

• You are taking vasoconstrictor medicines (bromocriptine, pergolide, lisuride, cabergoline, ergotamine) or any other oral or nasal decongestant (phenylephrine, ephedrine).

• You have a medical condition where anticholinergic activity is undesirable, particularly if you have risk factors for urinary retention (e.g., spinal cord injury, prostatic hyperplasia, prostate hypertrophy, or bladder outlet obstruction), as StopCold may increase the risk of urinary retention.

• You have hypertension and are being treated with non-steroidal anti-inflammatory drugs (NSAIDs).

• You are between 2 and 12 years of age, as studies have not been conducted in this patient group.

• You have blood clotting disorders.

• You develop a generalized feverish rash with pustules, stop taking StopCold and contact your doctor or seek medical attention immediately. See section 4.

• Skin allergy tests may yield false-negative results if you are taking StopCold within 3 days prior to testing; inform your doctor of this before testing.

• Sudden abdominal pain or rectal bleeding may occur with StopCold use due to inflammation of the colon (ischemic colitis). If these gastrointestinal symptoms occur, stop taking StopCold and contact your doctor or seek immediate medical attention. See section 4.

• Reduced blood flow to the optic nerve may occur with StopCold. If you experience sudden vision loss, stop taking StopCold and contact your doctor or seek immediate medical attention. See section 4.

• Cases of reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after using medicines containing pseudoephedrine. RPES and RCVS are rare conditions that may involve reduced blood flow to the brain. Stop using StopCold immediately and seek urgent medical help if you experience symptoms that could indicate RPES or RCVS (for symptoms, see section 4, "Possible side effects").

Children

StopCold is contraindicated in children under 2 years of age.

Taking StopCold with other medicines

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines.

Certain medicines may interact with StopCold; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

It is important to inform your doctor if you are taking or have recently taken any of the following medicines:

• Certain medicines used to treat depression (monoamine oxidase inhibitors).
• Certain medicines that lower blood pressure; antihypertensives (beta-adrenergic blockers).
• Some medicines used for stomach pain (antacids).
• Certain antihypertensives (methyldopa, guanethidine, or reserpine).
• Medicines used to treat heart problems (cardiac glycosides).
• Antibiotics containing linezolid.
• Certain medicines used in anesthesia (halogenated anesthetics).
• Certain sympathomimetic medicines (decongestants, appetite suppressants, stimulants).
• Certain vasoconstrictor medicines (bromocriptine, pergolide, lisuride, cabergoline, ergotamine).
• Non-steroidal anti-inflammatory drugs (NSAIDs).

Taking StopCold with food, drinks, and alcohol

StopCold should be swallowed whole with liquid and may be taken either on an empty stomach or with food. Do not chew or break the tablet.

Alcohol consumption and fatty meals are not recommended, as they may impair your ability to perform tasks.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of this medicine is not recommended during pregnancy or breastfeeding, as the medicine is excreted in breast milk.

Driving and using machines

There is no evidence that StopCold, when taken at the recommended dose, causes disturbances in attention, reaction capacity, or driving ability.

However, patients who intend to drive, perform potentially hazardous activities, or operate machinery are advised not to exceed the recommended dose and should consider their individual response to StopCold beforehand.

Athletes are advised that this medicine contains pseudoephedrine, which may result in a positive doping test.

StopCold contains pseudoephedrine, lactose, and sodium

Because this medicine contains pseudoephedrine, it may be subject to abuse; therefore, treatment duration should not exceed 2 to 3 weeks.

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take StopCold

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to always take your medicine.

Your doctor will tell you how long to take StopCold. Do not stop treatment early.

The recommended dose for adults and adolescents aged 12 years and older is 1 tablet of StopCold twice daily (morning and evening). Treatment should normally not exceed a period of 2 to 3 weeks.

Patients with kidney or liver problems should reduce the dose by half.

The tablet should be swallowed whole with some liquid and may be taken either on an empty stomach or with food. The tablet must not be split, chewed, or crushed.

If you think that the effect of StopCold is too strong or too weak, inform your doctor or pharmacist.

If you take more StopCold than you should

If you have taken more StopCold than you should, contact your doctor or pharmacist immediately.

A significant overdose may cause increased drowsiness, fatigue, symptoms of depression, and cardiac rhythm disturbances that may progress to unconsciousness or, conversely, stimulation with insomnia, hallucinations, tremors, and epileptic seizures.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 915 620 420.

If you forget to take StopCold

Do not take a double dose to make up for missed doses. Continue taking your next dose at the usual time.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Stop using StopCold immediately and seek urgent medical attention if you experience symptoms that could be signs of reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS).

These include:

• sudden, severe headache
• malaise
• vomiting
• confusion
• seizures
• changes in vision

The adverse effects reported with StopCold, classified by frequency, are:

• Frequent (may affect up to 1 in 10 people): tachycardia (irregular heartbeat), dry mouth, nausea, fatigue, dizziness, vertigo, headache, somnolence, nervousness, and insomnia.
• Uncommon (may affect up to 1 in 100 people): anxiety and agitation.
• Rare (may affect up to 1 in 1,000 people): arrhythmia (irregular heartbeat), vomiting, hepatic function disorders (elevation of liver enzymes and bilirubin), hypersensitivity reactions (including anaphylactic shock), seizures, tremor, hallucinations, difficulty urinating, dry skin, pruritus, increased sweating, pallor, hypertension.
• Very rare (may affect up to 1 in 10,000 people): dysgeusia (disturbance of taste sensation), stroke, psychiatric disorders, drug-related rash, angioneurotic edema (sudden onset of red hives and wheals), and cardiovascular collapse.
• Frequency not known (cannot be estimated from available data): serious conditions affecting the blood vessels in the brain known as reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS), aggression, confusion, depression, involuntary and repetitive movements caused by contraction of one or more muscles (tics), exaggerated sense of well-being (euphoria), suicidal thoughts, abnormal sensations in the skin (paresthesia), restlessness, prolonged abnormal muscle contractions (dystonia), involuntary movements (dyskinesia), memory loss (amnesia), memory problems, fainting (syncope), inflammation of the colon due to insufficient blood supply (ischemic colitis), diarrhea, abdominal discomfort, dyspnea (difficulty breathing), visual accommodation disorder (ocular disorder), blurred vision, mydriasis (abnormal dilation of the pupils), eye pain, visual impairment, photophobia (abnormal intolerance to visual perception of light), uncontrolled circular eye movements (oculogyric crisis), reduced blood flow to the optic nerve (ischemic optic neuropathy), erectile dysfunction (persistent inability to achieve and maintain an erection sufficient for satisfactory sexual performance), urinary incontinence (enuresis), urinary retention (difficulty emptying the bladder), acute generalized exanthematous pustulosis (severe skin reactions characterized by fever and numerous small superficial pustules appearing in extensive red areas), pruritus (itching), palpitations, myocardial injury causing cardiac arrest or severe disturbance of heartbeat rhythm due to obstruction of the corresponding artery or arteries (myocardial infarction), low blood pressure (hypotension), joint pain (arthralgia), muscle pain (myalgia), swelling (edema), malaise.

Description of some adverse reactions:

Pruritus (itching) has been reported in some patients after discontinuation of treatment.

At the first signs of allergic reaction to treatment with StopCold, discontinue the medication.

In post-marketing experience, isolated cases of hepatitis have been reported when cetirizine is administered alone.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of StopCold

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use StopCold after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of StopCold

• The active substances are cetirizine (as dihydrochloride) and pseudoephedrine (as hydrochloride).
• The other components are: hypromellose (E 464), microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, lactose, sodium croscarmellose, titanium dioxide (E 171), macrogol 400.

Nature of the product and pack contents

StopCold is presented as prolonged-release tablets. The tablets are white, round and biconvex.

Each pack contains 20 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

UCB Pharma, S.A.

Plaza de Manuel Gómez Moreno, s/n, Edificio Bronce, Planta 5, 28020 Madrid

Spain

Manufacturer:

Aesica Pharmaceuticals, S.r.l.

Via Praglia 15

I-10044 Pianezza (TO) - Italy

Date of the most recent revision of this leaflet: 04/2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) http://www.aemps.gob.es/