Acliz Plus25 mg+50 mg

Acliz Plus is a combination of meclizine, an antihistamine/antiemetic, and pyridoxine (vitamin B6). It is used for the following indications:

Established / commonly used indications

• Prevention and treatment of nausea, vomiting, and dizziness associated with motion sickness.
• Management of vertigo associated with diseases affecting the vestibular (inner ear) system.
• Nausea and vomiting of pregnancy (NVP): the meclizine component and the pyridoxine component are each used, alone or together, as a first-line, non-prescription-style option for mild-to-moderate nausea of pregnancy, on the advice of a physician. Pyridoxine alone is recommended by obstetric guidelines as an initial option for pregnancy-related nausea, and combining it with an antihistamine such as meclizine is a well-established approach for added symptom control.

Adjunct / supportive use

• The pyridoxine component may also be used to supplement vitamin B6 status in patients with an inadequate diet, in addition to its antiemetic role in this combination.

Use of Acliz Plus should always be guided by a physician, particularly during pregnancy or when other medical conditions are present.

Each dose of Meclizine + Pyridoxine typically contains:

• Meclizine hydrochloride (an antihistamine with antiemetic and anticholinergic properties)
• Pyridoxine hydrochloride (vitamin B6)

Strengths and dosage forms (tablet, chewable tablet, or oral liquid) vary by manufacturer; always check the product label for the exact composition of the specific brand dispensed.

Acliz Plus combines meclizine, a piperazine-derivative antihistamine with central anticholinergic and antiemetic activity, with pyridoxine (vitamin B6), a water-soluble vitamin with its own antiemetic effect, particularly in nausea of pregnancy. The combination is formulated to control nausea, vomiting, dizziness, and vertigo from more than one underlying mechanism.

It is typically available as oral tablets, chewable tablets, or an oral liquid/syrup, and is taken by mouth.

Acliz Plus belongs to the antihistamine / antiemetic therapeutic class (meclizine component), combined with a vitamin B6 supplement (pyridoxine component) that also has antiemetic activity.

Meclizine is a first-generation, piperazine-derivative H1-antihistamine. It is thought to reduce nausea, vomiting, and vertigo largely through central anticholinergic action on the vestibular apparatus and vomiting center in the brainstem, along with H1-receptor blockade, which reduces vestibular excitability and the associated nausea/vomiting reflex.

Pyridoxine (vitamin B6) is a co-factor in numerous enzymatic reactions, including neurotransmitter synthesis (e.g. serotonin, GABA). Its antiemetic mechanism in nausea of pregnancy is not fully elucidated, but it is thought to modulate neurotransmitter pathways involved in the vomiting reflex.

Together in Meclizine + Pyridoxine, the two components act on complementary pathways to reduce nausea, vomiting, and dizziness/vertigo.

Acliz Plus is administered orally. Tablets/chewable tablets may be taken with or without food; chewable forms should be chewed before swallowing. For motion sickness, take the dose about 1 hour before the activity likely to cause symptoms (e.g. travel). Do not crush or alter extended-release forms, if prescribed, unless directed by a physician.

Acliz Plus has the following clinically significant interactions, mainly related to its meclizine component:

• CNS depressants (alcohol, opioids, benzodiazepines, sedative-hypnotics, muscle relaxants): additive sedation and CNS depression; avoid or use with caution and medical supervision.
• Other anticholinergic drugs (e.g. tricyclic antidepressants, certain antipsychotics, other antihistamines): additive anticholinergic effects such as dry mouth, blurred vision, constipation, and urinary retention.
• Ototoxic drugs (e.g. high-dose aminoglycosides): meclizine may mask symptoms of ototoxicity (such as tinnitus and dizziness), potentially delaying recognition.
• Levodopa: pyridoxine, in high doses, may reduce the effectiveness of levodopa when levodopa is used without a decarboxylase inhibitor (e.g. carbidopa); this is less of a concern with standard low-dose combinations but should be discussed with a physician.

Inform your physician or pharmacist about all other medicines, supplements, and herbal products you are taking before starting Acliz Plus.

Side effects of Acliz Plus are primarily related to the meclizine component:

Common

• Drowsiness/sedation (most common)
• Dry mouth
• Blurred vision
• Headache
• Fatigue
• Mild gastrointestinal upset

Less common / serious

• Urinary retention/difficulty urinating
• Constipation
• Tachycardia (fast heartbeat)
• Allergic reactions (rash, hives, swelling of the face/lips/tongue, difficulty breathing) — seek immediate medical attention if these occur

Pyridoxine at the doses used in this combination is generally well tolerated; sensory neuropathy is a rare risk only associated with very high-dose, long-term pyridoxine use (see Precautions and Warnings).

Pregnancy: The pyridoxine component of Acliz Plus is an established, guideline-supported first-line option for nausea of pregnancy, and the combination with meclizine is commonly used under physician direction for this indication. Nonetheless, as with all medicines in pregnancy, Acliz Plus should be used only if clearly needed and if the potential benefit justifies the potential risk to the fetus; use only under the direction and supervision of a physician, especially in the first trimester.

Lactation: Meclizine and pyridoxine pass into breast milk in small amounts. Sedating antihistamines such as meclizine may cause drowsiness in a breastfeeding infant and may also reduce milk supply. Use during breastfeeding only if a physician determines the benefit outweighs the risk, and monitor the infant for excess sedation or poor feeding.

Use Acliz Plus with caution in the following situations:

• Sedation: may cause drowsiness; avoid driving, operating machinery, or performing other tasks requiring mental alertness until you know how it affects you. Avoid alcohol and other sedating substances, which can worsen this effect.
• Angle-closure glaucoma: the anticholinergic effect of meclizine can raise intraocular pressure; avoid use or use only under ophthalmic/medical supervision.
• Urinary retention/benign prostatic hyperplasia (BPH): anticholinergic effects may worsen urinary retention; use with caution.
• Asthma or chronic obstructive lung disease: anticholinergic and antihistamine effects may thicken respiratory secretions; use with caution.
• Elderly patients: may be more sensitive to sedative and anticholinergic effects (e.g. confusion, dry mouth, urinary retention); use the lowest effective dose.
• High-dose, prolonged pyridoxine use (well above the amount in this combination, and outside recommended use) has rarely been associated with peripheral sensory neuropathy; this is not expected at the doses used in this product when taken as directed, but avoid taking additional vitamin B6 supplements without medical advice.
• May mask symptoms of ototoxicity from other drugs and may make diagnosis of conditions such as appendicitis more difficult by suppressing nausea/vomiting; inform your physician if you are using Acliz Plus and develop new or worsening abdominal pain.

Overdose of Acliz Plus may cause marked drowsiness, confusion, hallucinations, dry mouth, blurred vision, fixed/dilated pupils, flushing, urinary retention, and in severe cases, seizures or cardiorespiratory depression, particularly in young children. If overdose is suspected, seek immediate medical attention or contact a poison control center/emergency services right away. Do not attempt to treat an overdose at home without professional medical guidance.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Pediatric use

Acliz Plus is generally not recommended in children younger than 12 years for motion sickness, and safety and efficacy have not been established in this age group for the other indications; use only if specifically directed by a pediatrician, as children may be more susceptible to anticholinergic side effects and paradoxical excitation.

Elderly

Elderly patients may be more sensitive to the sedative and anticholinergic effects of the meclizine component (drowsiness, confusion, dry mouth, urinary retention); use the lowest effective dose and monitor closely.

Renal/hepatic impairment

No well-established dose adjustment is defined; use with caution and physician guidance, as meclizine is metabolized primarily by the liver.

Duration of treatment with Acliz Plus depends on the indication: for motion sickness, it is typically used short-term, only for the duration of travel or exposure to the triggering activity; for vertigo or nausea of pregnancy, it may be used for a longer period as directed by a physician, with periodic reassessment of the need for continued treatment.

Antihistamine / Antiemetic (meclizine) combined with a Vitamin B6 supplement / antiemetic adjunct (pyridoxine)

The meclizine component of Meclizine + Pyridoxine acts as a central anticholinergic and H1-receptor antagonist, reducing vestibular stimulation and the resulting nausea, vomiting, and vertigo. The pyridoxine (vitamin B6) component contributes additional antiemetic activity through effects on neurotransmitter metabolism, complementing the action of meclizine, particularly in nausea of pregnancy.

Acliz Plus is not recommended for children under 12 years of age for motion sickness, and its safety and efficacy for other indications in children have not been established. In older children (12 years and above) it may be used for motion sickness at adult dosing, under caregiver/physician guidance, with attention to increased sensitivity to sedation and anticholinergic effects compared with adults.